TPLC - Total Product Life Cycle

• 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 Code: QIH
• Regulation Number: 892.2050
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
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
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 IMAGING
	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, 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
MRIMATH LLC
	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	2
PHILIPS HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	2
QUIBIM S.L.
	SUBSTANTIALLY EQUIVALENT	1
QURE.AI TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	4
REBRAIN, SAS
	SUBSTANTIALLY EQUIVALENT	2
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	7
SIMBIOSYS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SMART SOFT HEALTHCARE
	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

MDR Year	MDR Reports	MDR Events
2024	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Swelling/ Edema	1	1

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