The following data is part of a premarket notification filed by Adas3d Medical S.l with the FDA for Adas 3d.
| Device ID | K210850 |
| 510k Number | K210850 |
| Device Name: | ADAS 3D |
| Classification | System, Image Processing, Radiological |
| Applicant | Adas3D Medical S.L Paris 179, 2-2 Barcelona, ES 08036 |
| Contact | Antonio Riu |
| Correspondent | Antonio Riu Adas3D Medical S.L Paris 179, 2-2 Barcelona, ES 08036 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-22 |
| Decision Date | 2021-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08437021722031 | K210850 | 000 |
| 08437021722055 | K210850 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ADAS 3D 79290357 not registered Live/Pending |
ADAS3D MEDICAL S.L. 2020-06-15 |