The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Multix Fusion Max.
| Device ID | K162971 |
| 510k Number | K162971 |
| Device Name: | Multix Fusion Max |
| Classification | System, X-ray, Stationary |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 40 LIBERTY BOULEVARD, MAIL CODE 65-1A Malvern, PA 19355 |
| Contact | Denise Adams |
| Correspondent | Denise Adams SIEMENS MEDICAL SOLUTIONS USA, INC. 40 LIBERTY BOULEVARD, MAIL CODE 65-1A Malvern, PA 19355 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-25 |
| Decision Date | 2016-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869050713 | K162971 | 000 |