Multitom Rax
Interventional Fluoroscopic X-ray System
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 Multitom Rax.
Pre-market Notification Details
| Device ID | K152928 |
| 510k Number | K152928 |
| Device Name: | Multitom Rax |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 40 LIBERTY BLVD Malvern, PA 19355 |
| Contact | Darren A. Dorman |
| Correspondent | Darren A. Dorman SIEMENS MEDICAL SOLUTIONS USA, INC. 40 LIBERTY BLVD Malvern, PA 19355 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-05 |
| Decision Date | 2015-11-13 |
| Summary: | summary |
Trademark Results [Multitom Rax]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MULTITOM RAX 79188057 5238589 Live/Registered |
Siemens Healthcare GmbH 2016-02-26 |
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