MULTIX Impact
System, X-ray, Stationary
Siemens Medical Solutions USA, Inc.
The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Multix Impact.
Pre-market Notification Details
| Device ID | K193089 |
| 510k Number | K193089 |
| Device Name: | MULTIX Impact |
| Classification | System, X-ray, Stationary |
| Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mailcode 65-IA Malvern, PA 19355 |
| Contact | Martin Rajchel |
| Correspondent | Martin Rajchel Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mailcode 65-IA 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 | 2019-11-06 |
| Decision Date | 2020-03-20 |
Trademark Results [MULTIX Impact]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MULTIX IMPACT 79255719 5911313 Live/Registered |
Siemens Healthcare GmbH 2018-12-10 |
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