syngo.CT Lung CAD (Version VD30)
FDA 510(k) K231157 · Siemens Healthcare GmbH
510(k) numberK231157
Submission
- Device name
- syngo.CT Lung CAD (Version VD30)
- Applicant
- Siemens Healthcare GmbH
Forchheim, DE - Received
- April 24, 2023
- Decision date
- July 19, 2023
- 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 |
|---|---|---|---|
| K254075 | Synapse Lung Nodule AIOEB · Traditional | Fujifilm Corporation | 05/27/2026SE |
| 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 |
| 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.
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|---|---|---|
| K253264 | myAblation Guide (VC10A)QTZ · Traditional | 06/16/2026SE |
| K253689 | syngo Dynamics (VA41F)QIH · Traditional | 04/10/2026SE |
| K252548 | AI-Rad Companion Organs RTQKB · Traditional | 04/10/2026SE |
| K253057 | AI-Rad Companion Brain MRQIH · Traditional | 01/22/2026SE |
| K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…LNH · Traditional | 12/19/2025SE |
| K252608 | AI-Rad Companion Prostate MRLLZ · Traditional | 09/09/2025SE |
| K250443 | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileLNH · Traditional | 06/16/2025SE |
| K242551 | syngo Dynamics (Version VA41D)QIH · Traditional | 04/03/2025SE |
| K242745 | AI-Rad Companion Organs RTQKB · Traditional | 03/27/2025SE |
| K241770 | Prostate MR AI (VA10A)QDQ · Traditional | 03/05/2025SE |
Questions and answers
When was syngo.CT Lung CAD (Version VD30) cleared by the FDA?
syngo.CT Lung CAD (Version VD30) (K231157) received a 510(k) decision of Substantially Equivalent on July 19, 2023, 86 days after the submission was received.
What is the product code of K231157?
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.