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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 Code | QIH |
| Regulation Number |
892.2050
|
|---|
| Device Class |
2
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
| 3D-SIDE SA |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| ALPHA INTELLIGENCE MANIFOLDS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| AMCAD BIOMED CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ARTERYS INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| AXIAL MEDICAL PRINTING LIMITED |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BRAINLAB AG |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CAPTION HEALTH |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| CASIS CARDIAC SIMULATION & IMAGING SOFTWARE |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CEEVRA, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CHANGE HEALTHCARE CANADA COMPANY |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CIRCLE CARDIOVASCULAR IMAGING INC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CLARIPI INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CLARIUS MOBILE HEALTH CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CLEARPOINT NEURO, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CORELINE SOFT CO.,LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CORTECHS LABS, INC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CYCLE CLARITY |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| DEEPHEALTH, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| DIA IMAGING ANALYSIS LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
5
|
| DYAD MEDICAL, INC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| EKO.AI PTE. LTD. D/B/A US2.AI |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ELAITRA LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| EVER FORTUNE. AI CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| EXO INC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| 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
|
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
|
| ISCHEMA VIEW 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
|
| MRIGUIDANCE B.V |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MRIGUIDANCE B.V. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MRLGUIDANCE B.V. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| NEOSOMA INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| OLEA MEDICAL |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| PHILIPS HEALTHCARE |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| QURE.AI TECHNOLOGIES |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| REBRAIN, SAS |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| SIEMENS HEALTHCARE GMBH |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SIEMENS MEDICAL SOLUTIONS USA INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SIEMENS MEDICAL SOLUTIONS USA, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
4
|
| SMART SOFT HEALTHCARE AD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SURGICAL INFORMATION SCIENCES, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| 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
|
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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