The following data is part of a premarket notification filed by Siemens Medical Solutions with the FDA for Multitom Rax With True2scale Body Scan Option.
| Device ID | K212212 |
| 510k Number | K212212 |
| Device Name: | Multitom Rax With True2scale Body Scan Option |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Siemens Medical Solutions 40 Liberty Boulevard Malvern, PA 19355 |
| Contact | Denise Adams |
| Correspondent | Denise Adams Siemens Medical Solutions 40 Liberty Boulevard 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 | 2021-07-15 |
| Decision Date | 2022-02-18 |