FDA product code OEB: Lung Computed Tomography System, Computer-Aided Detection
OEB is the FDA product code for lung computed tomography system, computer-aided detection. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Radiology panel. FDA has cleared 20 510(k) submissions under OEB, 7 in the last five years, from 16 different applicants. The average 510(k) review took 142 days (median 140); 222 days on average over the last three years.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Lung Computed Tomography System, Computer-Aided Detection |
| Device class | Class II |
| Regulation | 21 CFR 892.2050 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for OEB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 2 | 188 |
| 2021 | 2 | 204 |
| 2022 | 1 | 185 |
| 2023 | 2 | 176 |
| 2025 | 3 | 285 |
| 2026 | 1 | 160 |
Compare with all 510(k) review times · Search every OEB clearance
Top OEB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Coreline Soft Co., Ltd. | 2 | 2025-12-03 |
| Siemens Healthcare GmbH | 2 | 2023-07-19 |
| Siemens AG Medical Solutions | 2 | 2015-05-12 |
| Medicsight | 2 | 2004-07-22 |
| Fujifilm Corporation | 1 | 2026-05-27 |
11 more applicants have OEB clearances. See the full list in Caduvo.
Most recent OEB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254075 | Fujifilm Corporation | Synapse Lung Nodule AI | 2026-05-27 | 160 |
| K251203 | Coreline Soft Co., Ltd. | AVIEW Lung Nodule CAD | 2025-12-03 | 229 |
| K240554 | Infervision Medical Technology Co., Ltd. | InferRead Lung CT.AI | 2025-05-16 | 443 |
| K242919 | V5med, Inc. | V5med Lung AI | 2025-03-27 | 184 |
| K231157 | Siemens Healthcare GmbH | syngo.CT Lung CAD (Version VD30) | 2023-07-19 | 86 |
Recalls for OEB devices
openFDA lists no recalls for product code OEB.
Frequently asked questions
What is FDA product code OEB?
OEB is the FDA product code for lung computed tomography system, computer-aided detection. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Radiology panel.
What device class is OEB?
Class II, regulation 21 CFR 892.2050. Typical premarket route: 510(k).
How long does a 510(k) take for product code OEB?
Across 20 cleared submissions the average was 142 days from receipt to decision (median 140).
Which companies have the most OEB clearances?
Coreline Soft Co., Ltd. (2); Siemens Healthcare GmbH (2); Siemens AG Medical Solutions (2); Medicsight (2); Fujifilm Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OEB
- Run a recall and safety report across every OEB manufacturer
- Watch product code OEB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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