Data / Medical devices / Lung Computed Tomography System, Computer-Aided Detection
Lung Computed Tomography System, Computer-Aided Detection (OEB): 8 FDA-registered makers in 6 countries
8 establishments in 6 countries are registered with the FDA to make Lung Computed Tomography System, Computer-Aided Detection (product code OEB, Class 2, 21 CFR 892.2050). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 20 510(k) clearances under this code, the latest on May 27, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- OEB
- Device class
- 2
- Regulation
- 892.2050
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| Germany | 2 |
| United States | 2 |
| China | 1 |
| South Korea | 1 |
| Japan | 1 |
| France | 1 |
Makers of Lung Computed Tomography System, Computer-Aided Detection
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthineers AG | FORCHHEIM Bavaria, Germany | Manufacturer | 6 | July 19, 2023 | 0 | 0 | 0 | api.fda.gov |
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing, China | Complaint file establishment, Manufacturer | 2 | May 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Coreline Soft Co., Ltd. | Seoul, South Korea | Complaint file establishment, Manufacturer | 2 | December 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Mevis Medical Solutions AG | Bremen, Germany | Complaint file establishment, Manufacturer | 2 | February 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Riverain Technologies | Miamisburg, OH, United States | Manufacturer | 2 | December 5, 2022 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Corporation Medical Systems Research & Development Center Minamiaoyama | Minato Tokyo, Japan | Manufacturer | 1 | May 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ge Medical Systems SCS | Buc, France | Manufacturer | 1 | November 18, 2004 | 0 | 0 | 0 | api.fda.gov |
| Hologic, Inc. | Newark, DE, United States | Complaint file establishment, Manufacturer | 1 | December 21, 2007 | 0 | 0 | 0 | api.fda.gov |
Updated May 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.