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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device automated radiological image processing software
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 SA
  SUBSTANTIALLY EQUIVALENT 2
ADRA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
AIDOC MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 3
ALPHA INTELLIGENCE MANIFOLDS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMCAD BIOMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ARTERYS INC.
  SUBSTANTIALLY EQUIVALENT 2
AXIAL MEDICAL PRINTING LIMITED
  SUBSTANTIALLY EQUIVALENT 2
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 1
CAPTION HEALTH
  SUBSTANTIALLY EQUIVALENT 2
CARLSMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
CASIS CARDIAC SIMULATION & IMAGING SOFTWARE
  SUBSTANTIALLY EQUIVALENT 1
CEEVRA, INC.
  SUBSTANTIALLY EQUIVALENT 2
CHANGE HEALTHCARE CANADA COMPANY
  SUBSTANTIALLY EQUIVALENT 1
CIRCLE CARDIOVASCULAR IMAGING
  SUBSTANTIALLY EQUIVALENT 1
CIRCLE CARDIOVASCULAR IMAGING INC
  SUBSTANTIALLY EQUIVALENT 1
CLARIPI INC.
  SUBSTANTIALLY EQUIVALENT 1
CLARIUS MOBILE HEALTH CORP.
  SUBSTANTIALLY EQUIVALENT 2
CLEARPOINT NEURO, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORELINE SOFT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORELINE SOFT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORTECHS LABS, INC
  SUBSTANTIALLY EQUIVALENT 1
CUREMETRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
CYCLE CLARITY
  SUBSTANTIALLY EQUIVALENT 1
DASI SIMULATIONS
  SUBSTANTIALLY EQUIVALENT 1
DEEPHEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIA IMAGING ANALYSIS LTD
  SUBSTANTIALLY EQUIVALENT 5
DIA IMAGING ANALYSIS LTD.
  SUBSTANTIALLY EQUIVALENT 1
DISIOR LTD
  SUBSTANTIALLY EQUIVALENT 2
DYAD MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
EKO.AI PTE. LTD D/B/A US2.AI
  SUBSTANTIALLY EQUIVALENT 1
EKO.AI PTE. LTD. D/B/A US2.AI
  SUBSTANTIALLY EQUIVALENT 1
ELAITRA LTD
  SUBSTANTIALLY EQUIVALENT 1
EOS IMAGING
  SUBSTANTIALLY EQUIVALENT 2
EVER FORTUNE. AI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EVER FORTUNE.AI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EXO INC
  SUBSTANTIALLY EQUIVALENT 2
EZRA AI INC.
  SUBSTANTIALLY EQUIVALENT 1
FEOPS NV
  SUBSTANTIALLY EQUIVALENT 1
FORMUS LABS, LTD
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS,
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GENESIS SOFTWARE INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 2
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
IMBIO, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMEKA SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INHEART, SAS
  SUBSTANTIALLY EQUIVALENT 1
INNOLITICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
INVISION MEDICAL TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ISCHEMA VIEW INC.
  SUBSTANTIALLY EQUIVALENT 1
ISCHEMAVIEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
JLK INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL METRICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDICALIP CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDIPIXEL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDO DX PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDO.AI
  SUBSTANTIALLY EQUIVALENT 1
MIGHTY OAK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MRIGUIDANCE B.V
  SUBSTANTIALLY EQUIVALENT 2
MRIGUIDANCE B.V.
  SUBSTANTIALLY EQUIVALENT 1
MRLGUIDANCE B.V.
  SUBSTANTIALLY EQUIVALENT 1
NEOSOMA INC.
  SUBSTANTIALLY EQUIVALENT 1
OLEA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ONTACT HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OVERJET, INC
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
QUIBIM S.L.
  SUBSTANTIALLY EQUIVALENT 1
QURE.AI TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 3
REBRAIN, SAS
  SUBSTANTIALLY EQUIVALENT 1
RELU BV
  SUBSTANTIALLY EQUIVALENT 1
SCREENPOINT MEDICAL B.V.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS U.S.A.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 5
SIMBIOSYS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMART SOFT HEALTHCARE AD
  SUBSTANTIALLY EQUIVALENT 1
SOFTWARE NEMOTEC S.L.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SUBTLE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL INFORMATION SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 3
SYDNEY NEUROIMAGING ANALYSIS CENTRE PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
SYNAPSICA
  SUBSTANTIALLY EQUIVALENT 1
TOMTEC IMAGING SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1
ULTROMICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ULTROMICS LTD
  SUBSTANTIALLY EQUIVALENT 1
VIDEAHEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
VISAGE IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 1
VIZ.AI, INC.
  SUBSTANTIALLY EQUIVALENT 2
VUNO INC.
  SUBSTANTIALLY EQUIVALENT 1
WHITERABBIT.AI INC.
  SUBSTANTIALLY EQUIVALENT 1
YUKUN (BEIJING) TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

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