AVIEW Lung Nodule CAD
FDA 510(k) K251203 · Coreline Soft Co., Ltd.
510(k) numberK251203
Submission
- Device name
- AVIEW Lung Nodule CAD
- Applicant
- Coreline Soft Co., Ltd.
Seoul, KR - Received
- April 18, 2025
- Decision date
- December 3, 2025
- 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 |
| 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 |
|---|---|---|
| K243689 | AviewQIH · Special | 03/19/2025SE |
| K243696 | Aview CacQIH · Special | 02/14/2025SE |
| K233211 | Aview CacQIH · Traditional | 03/29/2024SE |
| K221592 | AVIEW Lung Nodule CADOEB · Traditional | 02/24/2023SE |
| K214036 | AviewQIH · Traditional | 12/23/2022SE |
| K220408 | Aview RT AcsQKB · Traditional | 11/10/2022SE |
| K201710 | A View LCSLLZ · Traditional | 10/16/2020SE |
| K200714 | AviewLLZ · Traditional | 08/26/2020SE |
| K193220 | Aview LCSLLZ · Traditional | 05/05/2020SE |
| K192040 | AVIEW ModelerLLZ · Traditional | 12/20/2019SE |
Questions and answers
When was AVIEW Lung Nodule CAD cleared by the FDA?
AVIEW Lung Nodule CAD (K251203) received a 510(k) decision of Substantially Equivalent on December 3, 2025, 229 days after the submission was received.
What is the product code of K251203?
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.