The following data is part of a premarket notification filed by Philips Medical Systems Dmc Gmbh with the FDA for Digitaldiagnost C90.
| Device ID | K202564 |
| 510k Number | K202564 |
| Device Name: | DigitalDiagnost C90 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Philips Medical Systems DMC GmbH Röntgenstraße 24 Hamburg, DE 22335 |
| Contact | Ming Xiao |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MQB |
| Subsequent Product Code | KPR |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-09-04 |
| Decision Date | 2020-09-30 |