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 | K183272 |
| 510k Number | K183272 |
| Device Name: | AI Rad Companion (Engine) |
| Classification | System, Image Processing, Radiological |
| Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Blvd. Malvern, PA 19355 |
| Contact | Kimberly Mangum |
| Correspondent | Kimberly Mangum Siemens Medical Solutions USA, Inc. 40 Liberty Blvd. 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 | 2018-11-23 |
| Decision Date | 2019-02-01 |
| Summary: | summary |