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TPLC - Total Product Life Cycle
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Device automated radiological image processing software
Regulation Description Medical image management and processing system.
Definition To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.
Product CodeQIH
Regulation Number 892.2050
Device Class 2


Premarket Reviews
ManufacturerDecision
3D-SIDE S.A.
  SUBSTANTIALLY EQUIVALENT 2
ADAS3D MEDICAL S.L
  SUBSTANTIALLY EQUIVALENT 1
ADRA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
AIDOC MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 4
AIRS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALPHA INTELLIGENCE MANIFOLDS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMCAD BIOMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ANGIOWAVE IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTERYS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ARTRYA LIMITED
  SUBSTANTIALLY EQUIVALENT 2
AUDAX D.O.O.
  SUBSTANTIALLY EQUIVALENT 1
AUGMEDIT B.V.
  SUBSTANTIALLY EQUIVALENT 1
AVATAR MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AXIAL MEDICAL PRINTING LIMITED
  SUBSTANTIALLY EQUIVALENT 3
BEIJING INFERVISION HEALTHCARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BODYVISION MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB , LTD.
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 2
BRIGHTHEART
  SUBSTANTIALLY EQUIVALENT 2
BUNKERHILL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CAPTION HEALTH
  SUBSTANTIALLY EQUIVALENT 2
CAREVERSE TECHNOLOGY PTE. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARLSMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
CASIS CARDIAC SIMULATION & IMAGING SOFTWARE
  SUBSTANTIALLY EQUIVALENT 1
CEEVRA, INC.
  SUBSTANTIALLY EQUIVALENT 3
CHANGE HEALTHCARE CANADA COMPANY
  SUBSTANTIALLY EQUIVALENT 1
CIRCLE CARDIOVASCULAR IMAGING
  SUBSTANTIALLY EQUIVALENT 1
CIRCLE CARDIOVASCULAR IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 3
CLARIPI, INC.
  SUBSTANTIALLY EQUIVALENT 1
CLARIUS MOBILE HEALTH CORP.
  SUBSTANTIALLY EQUIVALENT 4
CLEARPOINT NEURO, INC.
  SUBSTANTIALLY EQUIVALENT 1
CLEERLY, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORELINE SOFT CO.,LTD
  SUBSTANTIALLY EQUIVALENT 4
CORTECHS LABS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CUREMETRIX, INC.
  SUBSTANTIALLY EQUIVALENT 2
CYCLE CLARITY
  SUBSTANTIALLY EQUIVALENT 1
DASI SIMULATIONS
  SUBSTANTIALLY EQUIVALENT 1
DEEP BREATHE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEEPHEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 2
DENTSPLY SIRONA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DGNCT, LLC
  SUBSTANTIALLY EQUIVALENT 1
DIA IMAGING ANALYSIS, LTD.
  SUBSTANTIALLY EQUIVALENT 10
DISIOR, LTD.
  SUBSTANTIALLY EQUIVALENT 4
DURR DENTAL SE
  SUBSTANTIALLY EQUIVALENT 1
DYAD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EKO.AI PTE LTD. D/B/A US2.AI
  SUBSTANTIALLY EQUIVALENT 2
ELAITRA, LTD.
  SUBSTANTIALLY EQUIVALENT 1
EOS IMAGING
  SUBSTANTIALLY EQUIVALENT 4
EVER FORTUNE.AI, CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
EWOOSOFT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
EXO IMAGING
  SUBSTANTIALLY EQUIVALENT 1
EXO, INC.
  SUBSTANTIALLY EQUIVALENT 3
EZRA AI, INC.
  SUBSTANTIALLY EQUIVALENT 2
FEOPS NV
  SUBSTANTIALLY EQUIVALENT 1
FOQUS TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
FORMUS LABS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GALILEO CDS, INC.
  SUBSTANTIALLY EQUIVALENT 2
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GENESIS SOFTWARE INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 2
GLEAMER SAS
  SUBSTANTIALLY EQUIVALENT 1
HEARTLUNG CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HERMES MEDICAL SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 1
HI-D IMAGING AG
  SUBSTANTIALLY EQUIVALENT 1
HIGHRAD , LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUTOM, INC.
  SUBSTANTIALLY EQUIVALENT 1
HYPERFINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
IB LAB GMBH
  SUBSTANTIALLY EQUIVALENT 1
ICAD, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICARDIO.AI
  SUBSTANTIALLY EQUIVALENT 1
IMBIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMBIO, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMEKA SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
INHEART, SAS
  SUBSTANTIALLY EQUIVALENT 1
INNOLITICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
INVISION MEDICAL TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ISCHEMAVIEW, INC.
  SUBSTANTIALLY EQUIVALENT 5
JLK, INC.
  SUBSTANTIALLY EQUIVALENT 1
LARALAB GMBH
  SUBSTANTIALLY EQUIVALENT 1
LIGENCE UAB
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL IP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL METRICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDICREA INTERNATIONAL S.A.S. (MEDTRONIC)
  SUBSTANTIALLY EQUIVALENT 1
MEDIPIXEL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDO DX PTE. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDO.AI
  SUBSTANTIALLY EQUIVALENT 1
METAMORPHOSIS GMBH
  SUBSTANTIALLY EQUIVALENT 1
MIGHTY OAK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MRIGUIDANCE B.V.
  SUBSTANTIALLY EQUIVALENT 3
MRIMATH, LLC
  SUBSTANTIALLY EQUIVALENT 1
MRLGUIDANCE B.V.
  SUBSTANTIALLY EQUIVALENT 1
MSKAI
  SUBSTANTIALLY EQUIVALENT 1
MYCARDIUM AI LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NEOSOMA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEUROPHET., INC.
  SUBSTANTIALLY EQUIVALENT 1
NUREA
  SUBSTANTIALLY EQUIVALENT 1
OLEA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ONTACT HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ORTHO AI, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
OVERJET, INC.
  SUBSTANTIALLY EQUIVALENT 4
OXFORD BRAIN DIAGNOSTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PEARL, INC.
  SUBSTANTIALLY EQUIVALENT 2
PEEK HEALTH, S.A.
  SUBSTANTIALLY EQUIVALENT 3
PHANTOMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS ULTRASOUND, LLC
  SUBSTANTIALLY EQUIVALENT 1
PIE MEDICAL IMAGING BV
  SUBSTANTIALLY EQUIVALENT 1
PIUR IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 2
Q BIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUANTIB B.V.
  SUBSTANTIALLY EQUIVALENT 1
QUIBIM S.L.
  SUBSTANTIALLY EQUIVALENT 1
QURE.AI TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 4
REBRAIN, SAS
  SUBSTANTIALLY EQUIVALENT 2
RELU BV
  SUBSTANTIALLY EQUIVALENT 1
REMEDY LOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE MOLECULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCANDIAGS AG
  SUBSTANTIALLY EQUIVALENT 1
SCREENPOINT MEDICAL B.V.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
SHANGHAI UNITED IMAGING INTELLIGENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS HEALTHINEERS AG
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS U.S.A.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 9
SIMBIOSYS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SMART SOFT HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
SMART SOFT HEALTHCARE AD
  SUBSTANTIALLY EQUIVALENT 2
SOFTWARE NEMOTEC S.L.
  SUBSTANTIALLY EQUIVALENT 1
SORA NEUROSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SUBTLE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL INFORMATION SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 3
SYDNEY NEUROIMAGING ANALYSIS CENTRE PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYNAPSICA
  SUBSTANTIALLY EQUIVALENT 1
TERARECON,INC.
  SUBSTANTIALLY EQUIVALENT 3
THERAPIXEL
  SUBSTANTIALLY EQUIVALENT 2
TOMTEC IMAGING SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1
TRIBUSMED BEHEER BV
  SUBSTANTIALLY EQUIVALENT 1
ULTROMICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
VENT CREATIVITY
  SUBSTANTIALLY EQUIVALENT 1
VENTRIPOINT DIAGNOSTICS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIDEAHEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
VINBRAIN JOINT STOCK COMPANY
  SUBSTANTIALLY EQUIVALENT 1
VISAGE IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 1
VITAA MEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIZ. AI, INC.
  SUBSTANTIALLY EQUIVALENT 3
VUNO, INC.
  SUBSTANTIALLY EQUIVALENT 1
WHITERABBIT.AI, INC.
  SUBSTANTIALLY EQUIVALENT 1
YUKUN (BEIJING) TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 2 2
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 6 6
Data Problem 5 5
Patient Data Problem 4 4
Insufficient Information 2 2
Wrong Label 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Caption Health II Jul-22-2021
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