The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Multix Impact C.
| Device ID | K203340 |
| 510k Number | K203340 |
| Device Name: | MULTIX Impact C |
| Classification | System, X-ray, Stationary |
| Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Blvd Mail Code: 65-1A Malvern, PA 19355 |
| Contact | Martin Rajchel |
| Correspondent | Martin Rajchel Siemens Medical Solutions USA, Inc. 40 Liberty Blvd Mail Code: 65-1A Malvern, PA 19355 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-12 |
| Decision Date | 2021-01-06 |