The following data is part of a premarket notification filed by Philips Medical Systems Dmc Gmbh with the FDA for Digitaldiagnost.
| Device ID | K210692 |
| 510k Number | K210692 |
| Device Name: | DigitalDiagnost |
| Classification | System, X-ray, Stationary |
| Applicant | Philips Medical Systems DMC GmbH Roentgenstrasse 24-26 Hamburg, DE 22335 |
| Contact | Supriya Dalvi |
| Correspondent | Supriya Dalvi Philips Medical Systems DMC GmbH Roentgenstrasse 24-26 Hamburg, DE 22335 |
| Product Code | KPR |
| Subsequent Product Code | LLZ |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-08 |
| Decision Date | 2021-04-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DIGITALDIAGNOST 76567697 3096082 Live/Registered |
KONINKLIJKE PHILIPS ELECTRONICS N.V. 2003-12-17 |