FDA Product Code
FDA Product Code OEB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.2050
510(k) Clearances — 20 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254075 | Synapse Lung Nodule AI | Fujifilm Corporation | 2026-05-27 | Traditional | PDF ↗ |
| K251203 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | 2025-12-03 | Traditional | PDF ↗ |
| K240554 | InferRead Lung CT.AI | Infervision Medical Technology Co., Ltd. | 2025-05-16 | Traditional | PDF ↗ |
| K242919 | V5med Lung AI | V5med, Inc. | 2025-03-27 | Traditional | PDF ↗ |
| K231157 | syngo.CT Lung CAD (Version VD30) | Siemens Healthcare GmbH | 2023-07-19 | Traditional | PDF ↗ |
| K221592 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | 2023-02-24 | Traditional | PDF ↗ |
| K221612 | ClearRead CT | Riverain Technologies, Inc. | 2022-12-05 | Traditional | PDF ↗ |
| K203258 | syngo.CT Lung CAD | Siemens Healthcare GmbH | 2021-03-31 | Traditional | PDF ↗ |
| K201501 | Veolity | MeVis Medical Solutions AG | 2021-02-23 | Traditional | PDF ↗ |
| K192880 | InferRead Lung CT.AI | Beijing Infervision Technology Co., Ltd. | 2020-07-02 | Traditional | PDF ↗ |
| K193216 | syngo.CT Lung CAD | Siemens Medi Cal Solutions, Inc. | 2020-03-09 | Traditional | PDF ↗ |
| K161201 | ClearRead CT | Riverain Technologies, LLC | 2016-09-09 | Traditional | PDF ↗ |
| K143196 | syngo.CT Lung CAD | Siemens AG Medical Solutions | 2015-05-12 | Traditional | PDF ↗ |
| K043617 | IMAGECHECKER CT CAD SOFTWARE SYSTEM | Hologic, Inc. | 2007-12-21 | Traditional | PDF ↗ |
| K063877 | SYNGO LUNG CAD | Siemens Medical Solutions USA, Inc. | 2006-10-18 | Traditional | PDF ↗ |
| K042694 | ADVANCED LUNG ANALYSIS II | GE Medical Systems | 2004-11-18 | Traditional | PDF ↗ |
| K041807 | LUNG CAR 1.1 | Medicsight | 2004-07-22 | Special | PDF ↗ |
| K041380 | IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR | R2 Technology, Inc. | 2004-06-08 | Traditional | PDF ↗ |
| K033412 | MEDICLUNG, RELEASE 1 | Medicsight | 2003-12-30 | Traditional | PDF ↗ |
| K033374 | LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY | Siemens AG Medical Solutions | 2003-11-06 | Special | PDF ↗ |
Product code OEB · Class II · Radiology. Data: openFDA.