Data / Medical devices / Spain / Adas3d Medical S.L
Adas3d Medical S.L: FDA-registered device maker in Barcelona, Spain, 5 510(k) clearances
Adas3d Medical S.L is registered with the FDA (registration 3016461002) in Barcelona, Spain. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 9, 2024. Registered through 2026. 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.
- FDA registration number
- 3016461002
- Address
- Rambla Catalunya 53, 4H, Barcelona, Spain, 08007
- Owner or operator
- ADAS3D MEDICAL S.L (10062445)
- Roles
- Manufacturer
- First device listed
- January 29, 2020
- Registered through
- 2026
- Brand names listed
- ADAS 3D, Adas 3D Medical S.L
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 9, 2024 | K240791 | ADAS 3D | QIH | Substantially Equivalent | Adas3D Medical S.L. | accessdata.fda.gov |
| May 23, 2023 | K230803 | ADAS 3D | LLZ | Substantially Equivalent | Adas3D Medical S.L. | accessdata.fda.gov |
| September 3, 2021 | K212421 | ADAS 3D | LLZ | Substantially Equivalent | Adas3D Medical S.L. | accessdata.fda.gov |
| April 5, 2021 | K210850 | ADAS 3D | LLZ | Substantially Equivalent | Adas3D Medical S.L. | accessdata.fda.gov |
| January 15, 2020 | K191125 | ADAS 3D | LLZ | Substantially Equivalent | Galgo Medical S.L | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Automated Radiological Image Processing Software
Updated September 9, 2024. 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.