Lung Computed Tomography System, Computer-aided Detection
Radiology · 21 CFR 892.2050
To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review. A computer aided diagnosis, lung computed tomography system is a class 3 device under product code NRR.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
22 firms currently registered for this product code
Mevis Medical Solutions Ag
Bremen, DE
Siemens Healthineers Ag
FORCHHEIM Bavaria, DE
Ge Medical Systems Scs
BUC, FR
Fujifilm Corporation Medical Systems Research & Development Center Minamiaoyama
Minato Tokyo, JP
Canon Medical Informatics, Inc.
MINNETONKA, MN, US
Beijing Infervision Healthcare Medical Technology Co., Ltd.
Beijing, CN
Riverain Technologies
MIAMISBURG, OH, US
Hologic, Inc.
Newark, DE, US
Coreline Soft Co., Ltd.
Seoul, KR
Fujifilm Corporation
ASHIGARAKAMI-GUN Kanagawa, JP
Philips Medical Systems Technologies Ltd.
Haifa, IL
510(k) clearances
20 clearances for this product code
- Fujifilm CorporationMay 27, 2026
K254075 · Synapse Lung Nodule AI
- Coreline Soft Co., Ltd.Dec 3, 2025
K251203 · AVIEW Lung Nodule CAD
- Infervision Medical Technology Co., Ltd.May 16, 2025
K240554 · InferRead Lung CT.AI
- V5med, Inc.Mar 27, 2025
K242919 · V5med Lung AI
- Siemens Healthcare GmbHJul 19, 2023
K231157 · syngo.CT Lung CAD (Version VD30)
- Coreline Soft Co., Ltd.Feb 24, 2023
K221592 · AVIEW Lung Nodule CAD
- Riverain Technologies, Inc.Dec 5, 2022
K221612 · ClearRead CT
- Siemens Healthcare GmbHMar 31, 2021
K203258 · syngo.CT Lung CAD