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Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems
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Philips Medical Systems Nederland BV
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✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
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Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades
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Philips Medical Systems Nederland BV
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
inHEART MODELS
|
Inheart, Sas
|
✓
Registered with US (FDA)
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—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
✓
Registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
Instrument Exit Point on Touch Surgery™ Aide
|
Covidien
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
INT Contour
|
Carina Medical, LLC
|
✓
Registered with US (FDA)
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—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
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Intelligent NR
|
Canon Inc
|
✓
Registered with US (FDA)
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—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
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—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
iNtuition-Structural Heart Module
|
Terarecon,Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
InVision Precision Cardiac Amyloid
|
Invision Medical Technology Corporation
|
✓
Registered with US (FDA)
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—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
InVision Precision LVEF (LVEF)
|
Invision Medical Technology Corporation
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
iQMR
|
Medic Vision Imaging Solutions
|
✓
Registered with US (FDA)
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—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
iQ-solutions
|
Sydney Neuroimaging Analysis Centre Pty, Ltd.
|
✓
Registered with US (FDA)
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—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
|
✓
Registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
IQ-UIP
|
Imbio, LLC
|
✓
Registered with US (FDA)
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—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
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—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
IRISeg
|
Intuitive Surgical, Inc.
|
✓
Registered with US (FDA)
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—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
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—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
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IRIS INTELLIGENT RETINAL IMAGING SYSTEM
|
Intelligent Retinal Imaging Systems, LLC
|
✓
Registered with US (FDA)
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—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
IRNF App
|
Apple, Inc.
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
Irregular Rhythm Notification Feature (IRNF)
|
Apple, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
iSchemaView RAPID
|
Ischemaview, Inc.
|
✓
Registered with US (FDA)
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—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
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—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
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JAZZ
|
AI Medical AG
|
✓
Registered with US (FDA)
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—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
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—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
JBS-LVO
|
JLK, Inc.
|
✓
Registered with US (FDA)
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—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
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—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class
|
Element Science, Inc.
|
✓
Registered with US (FDA)
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—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
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—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
JLK-ICH
|
JLK, Inc.
|
✓
Registered with US (FDA)
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—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
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—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
JLK-NCCT
|
JLK, Inc.
|
✓
Registered with US (FDA)
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—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
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—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
JLK-SDH
|
JLK, Inc.
|
✓
Registered with US (FDA)
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—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
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—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
KardiaAI
|
AliveCor, Inc.
|
✓
Registered with US (FDA)
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—
Not registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
KidneyIntelX.dkd
|
Renalytix Ai, Inc.
|
✓
Registered with US (FDA)
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—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
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—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
KIDScore D3
Vitrolife AS
Registered with
-
US
US (FDA)
-
UK
UK (MHRA)
-
EU
EU (EUDAMED)
|
Vitrolife AS
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
Kneevoice Cartilage Evaluation System (750-3600-001)
|
Kneevoice, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
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—
Not registered with EU (EUDAMED)
|
|
KOALA
|
IB Lab GmbH
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
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—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
Koios DS
Koios Medical, Inc.
Registered with
-
US
US (FDA)
-
UK
UK (MHRA)
-
CA
Canada (Health Canada)
-
EU
EU (EUDAMED)
|
Koios Medical, Inc.
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
Koios DS for Breast
|
Koios Medical, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
Kosmos
EchoNous, Inc
Registered with
-
US
US (FDA)
-
AU
AU (TGA)
-
EU
EU (EUDAMED)
|
EchoNous, Inc
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
✓
Registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
LARALAB
|
Laralab GmbH
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
LensHooke X12 PRO Semen Analysis System
|
Bonraybio Co., Ltd.
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer
|
Bonraybio Co., Ltd.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
|
Bonraybio Co., Ltd.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer
|
Bonraybio Co., Ltd.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Libby Echo:Prio
|
Dyad Medical, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Ligence Heart
|
Ligence Uab
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Lightning Viewer
|
Nexsys Electronics Inc. Dba Medweb
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
Limbus Contour
Limbus Ai, Inc.
Registered with
-
US
US (FDA)
-
UK
UK (MHRA)
-
CA
Canada (Health Canada)
-
AU
AU (TGA)
-
EU
EU (EUDAMED)
|
Limbus Ai, Inc.
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
✓
Registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
LingOral Dental Design System
|
Hangzhou ChohoTech Co., Ltd
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
LINQ II Insertable Cardiac Monitor
Medtronic, Inc
Registered with
-
US
US (FDA)
-
UK
UK (MHRA)
-
CA
Canada (Health Canada)
|
Medtronic, Inc
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
|
Medtronic, Inc
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
|
Medtronic, Inc
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
LiverMultiScan
Perspectum Ltd
Registered with
-
US
US (FDA)
-
UK
UK (MHRA)
-
EU
EU (EUDAMED)
|
Perspectum Ltd
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
LiverMultiScan (LMSv3)
|
Perspectum Diagnostics, Ltd.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
LiverMultiScan v5 (LMSv5)
|
Perspectum Ltd
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
LiverMultiScan (v6.0)
|
Perspectum Ltd
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
LiverSmart
|
Resonance Health Analysis Services Pty, Ltd.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Logicon Caries Detection Software
|
Carestream Dental, LLC
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
