The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc with the FDA for Ai-rad Companion Organs Rt.
| Device ID | K221305 |
| 510k Number | K221305 |
| Device Name: | AI-Rad Companion Organs RT |
| Classification | Radiological Image Processing Software For Radiation Therapy |
| Applicant | Siemens Medical Solutions USA, Inc 40 Liberty Blvd. Mail Code 65-3 Malvern, PA 19355 |
| Contact | Kira Kuzmenchuk |
| Correspondent | Kira Kuzmenchuk Siemens Medical Solutions USA, Inc 40 Liberty Blvd. Mail Code 65-3 Malvern, PA 19355 |
| Product Code | QKB |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-05 |
| Decision Date | 2022-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869955667 | K221305 | 000 |