FDA-cleared K252261

InferCare RECIST

Beijing Infervision Healthcare Medical Technology Co., Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
N/A
Decision
2026-03-13
FDA-cleared K254016

MI View&GO

Siemens Medical Solutions USA, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
N/A
Decision
2026-02-10
FDA-cleared K253735

AV Vascular

Philips Medical Systems Nederland B.V.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Vascular
Decision
2026-01-22
FDA-cleared K240791

ADAS 3D

Adas3D Medical S.L

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
N/A
Decision
2024-09-09
FDA-cleared K233582

Rapid

iSchema View Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
N/A
Decision
2024-04-22
FDA-cleared K183489

D2P

3D Systems, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
N/A
Decision
2019-08-29
FDA-authorized DEN170022

QuantX

Quantitative Insights, Inc

FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
N/A
Decision
2017-07-19