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 |