The following data is part of a premarket notification filed by Siemens Healthcare Gmbh with the FDA for Ai-rad Companion Brain Mr.
| Device ID | K213706 |
| 510k Number | K213706 |
| Device Name: | AI-Rad Companion Brain MR |
| Classification | Automated Radiological Image Processing Software |
| Applicant | Siemens Healthcare GmBh 40 Liberty Blvd. Mail Code 65-1 Malvern, PA 19355 |
| Contact | Kira Kuzmenchuk |
| Correspondent | Kira Kuzmenchuk Siemens Healthcare GmBh 40 Liberty Blvd. Mail Code 65-1 Malvern, PA 19355 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-24 |
| Decision Date | 2022-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869298207 | K213706 | 000 |