The following data is part of a premarket notification filed by Siemens Medical Solutions Usa Inc. with the FDA for Ai-rad Companion Prostate Mr.
| Device ID | K193283 |
| 510k Number | K193283 |
| Device Name: | AI-Rad Companion Prostate MR |
| Classification | Automated Radiological Image Processing Software |
| Applicant | Siemens Medical Solutions USA Inc. 40 Liberty Blvd. Mail Code 65-3 Malvern, PA 19355 |
| Contact | Lauren Bentley |
| Correspondent | Lauren Bentley Siemens Medical Solutions USA Inc. 40 Liberty Blvd. Mail Code 65-3 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 | 2019-11-27 |
| Decision Date | 2020-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869257952 | K193283 | 000 |
| 04056869274638 | K193283 | 000 |