The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Multix Fusion Va30 & Va40.
| Device ID | K142049 |
| 510k Number | K142049 |
| Device Name: | MULTIX FUSION VA30 & VA40 |
| Classification | System, X-ray, Stationary |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 |
| Contact | Patricia D Jones |
| Correspondent | Patricia D Jones SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY 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 | 2014-07-28 |
| Decision Date | 2014-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869019925 | K142049 | 000 |
| 04056869019918 | K142049 | 000 |
| 04056869019901 | K142049 | 000 |
| 04056869019895 | K142049 | 000 |