Synapse Lung Nodule AI
FDA 510(k) clearance K254075 · decided 2026-05-27
Clearance details
- K-number
- K254075
- Device name
- Synapse Lung Nodule AI
- Applicant
- Fujifilm Corporation
- Decision
- Substantially Equivalent
- Date received
- 2025-12-18
- Decision date
- 2026-05-27
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- OEB
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Minato-Ku, Tokyo, JP
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AVIEW Lung Nodule CAD (K251203) | Coreline Soft Co., Ltd. | 2025-12-03 |
| InferRead Lung CT.AI (K240554) | Infervision Medical Technology Co., Ltd. | 2025-05-16 |
| V5med Lung AI (K242919) | V5med, Inc. | 2025-03-27 |
| syngo.CT Lung CAD (Version VD30) (K231157) | Siemens Healthcare GmbH | 2023-07-19 |
| AVIEW Lung Nodule CAD (K221592) | Coreline Soft Co., Ltd. | 2023-02-24 |
| ClearRead CT (K221612) | Riverain Technologies, Inc. | 2022-12-05 |
| syngo.CT Lung CAD (K203258) | Siemens Healthcare GmbH | 2021-03-31 |
| Veolity (K201501) | MeVis Medical Solutions AG | 2021-02-23 |
| InferRead Lung CT.AI (K192880) | Beijing Infervision Technology Co., Ltd. | 2020-07-02 |
| syngo.CT Lung CAD (K193216) | Siemens Medi Cal Solutions, Inc. | 2020-03-09 |
| ClearRead CT (K161201) | Riverain Technologies, LLC | 2016-09-09 |
| syngo.CT Lung CAD (K143196) | Siemens AG Medical Solutions | 2015-05-12 |
Recalls involving this device
No recalls on record reference this clearance.