The following data is part of a premarket notification filed by Siemens Medical Solution with the FDA for Multix Fusion.
| Device ID | K121513 |
| 510k Number | K121513 |
| Device Name: | MULTIX FUSION |
| Classification | System, X-ray, Stationary |
| Applicant | SIEMENS MEDICAL SOLUTION 51 VALLEY STREAM PKWY. Malvern, PA 19355 |
| Contact | Patricia D Jones |
| Correspondent | Patricia D Jones SIEMENS MEDICAL SOLUTION 51 VALLEY STREAM PKWY. 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 | 2012-05-21 |
| Decision Date | 2012-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869019888 | K121513 | 000 |