The following data is part of a premarket notification filed by Dicom Grid, Inc, Dba Ambra Health with the FDA for Ambra Proviewer.
| Device ID | K202335 |
| 510k Number | K202335 |
| Device Name: | Ambra ProViewer |
| Classification | System, Image Processing, Radiological |
| Applicant | Dicom Grid, Inc, Dba Ambra Health 199 Water St., 34th Floor New York, NY 10038 |
| Contact | Patrice Nedelec |
| Correspondent | Rafael Aguila Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 403 Ludlum, FL 33155 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-08-17 |
| Decision Date | 2020-09-04 |