The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Al-rad Companion (musculoskeletal).
| Device ID | K193267 |
| 510k Number | K193267 |
| Device Name: | Al-Rad Companion (Musculoskeletal) |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 |
| Contact | Alaine Medio |
| Correspondent | Alaine Medio Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-26 |
| Decision Date | 2020-03-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869251233 | K193267 | 000 |