The following data is part of a premarket notification filed by Philips Medical Systems Dmc Gmbh with the FDA for Philips Radiology Smart Assistant.
| Device ID | K212186 |
| 510k Number | K212186 |
| Device Name: | Philips Radiology Smart Assistant |
| Classification | System, X-ray, Stationary |
| Applicant | Philips Medical Systems DMC GmbH Roentgenstrasse 24-26 Hamburg, DE 22335 |
| Contact | Connie Pascual |
| Correspondent | Connie Pascual Philips Medical Systems DMC GmbH Roentgenstrasse 24-26 Hamburg, DE 22335 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-13 |
| Decision Date | 2021-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838104013 | K212186 | 000 |