The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc with the FDA for Luminos Drf Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax.
| Device ID | K173639 |
| 510k Number | K173639 |
| Device Name: | Luminos DRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Siemens Medical Solutions, Inc 40 Liberty Boulevard 65-1A Malvern, PA 19355 |
| Contact | Denise Adams |
| Correspondent | Denise Adams Siemens Medical Solutions, Inc 40 Liberty Boulevard 65-1A 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 | 2017-11-24 |
| Decision Date | 2018-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869269931 | K173639 | 000 |