The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Ai-rad Companion Engine.
| Device ID | K193294 |
| 510k Number | K193294 |
| Device Name: | AI-Rad Companion Engine |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| 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 | 2020-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869257921 | K193294 | 000 |