Synapse Lung Nodule AI
FDA 510(k) K254075 · Fujifilm Corporation
510(k) numberK254075
Submission
- Device name
- Synapse Lung Nodule AI
- Applicant
- Fujifilm Corporation
Minato-Ku, Tokyo, JP - Received
- December 18, 2025
- Decision date
- May 27, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OEB – Lung Computed Tomography System, Computer-Aided Detection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
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.
Other 510(k)s with product code OEB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251203 | AVIEW Lung Nodule CADOEB · Traditional | Coreline Soft Co., Ltd. | 12/03/2025SE |
| K240554 | InferRead Lung CT.AIOEB · Traditional | Infervision Medical Technology Co., Ltd. | 05/16/2025SE |
| K242919 | V5med Lung AIOEB · Traditional | V5med, Inc. | 03/27/2025SE |
| K231157 | syngo.CT Lung CAD (Version VD30)OEB · Traditional | Siemens Healthcare GmbH | 07/19/2023SE |
| K221592 | AVIEW Lung Nodule CADOEB · Traditional | Coreline Soft Co., Ltd. | 02/24/2023SE |
| K221612 | ClearRead CTOEB · Traditional | Riverain Technologies, Inc. | 12/05/2022SE |
| K203258 | syngo.CT Lung CADOEB · Traditional | Siemens Healthcare GmbH | 03/31/2021SE |
| K201501 | VeolityOEB · Traditional | MeVis Medical Solutions AG | 02/23/2021SE |
| K192880 | InferRead Lung CT.AIOEB · Traditional | Beijing Infervision Technology Co., Ltd. | 07/02/2020SE |
| K193216 | syngo.CT Lung CADOEB · Traditional | Siemens Medi Cal Solutions, Inc. | 03/09/2020SE |
More from Siemens Medi Cal Solutions, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253836 | FCT iStream Phase 2JAK · Traditional | 09/04/2026SE |
| K261170 | BA-004CCITX · Traditional | 08/12/2026SE |
| K260567 | EW10-EC02 Endoscopy Support ProgramQNP · Special | 08/07/2026SE |
| K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01FET · Special | 07/02/2026SE |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TEOQ · Traditional | 06/16/2026SE |
| K254189 | Synapse 3D Base Tools (V7.2)QIH · Traditional | 04/30/2026SE |
| K253862 | APERTO Lucent MRI SystemLNH · Traditional | 04/06/2026SE |
| K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…FDT · Traditional | 03/09/2026SE |
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFDS · Traditional | 02/17/2026SE |
| K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood…FDS · Special | 02/06/2026SE |
Questions and answers
When was Synapse Lung Nodule AI cleared by the FDA?
Synapse Lung Nodule AI (K254075) received a 510(k) decision of Substantially Equivalent on May 27, 2026, 160 days after the submission was received.
What is the product code of K254075?
The FDA product code is OEB – Lung Computed Tomography System, Computer-Aided Detection, a Class II (moderate risk) device regulated under 21 CFR 892.2050.