The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Ai-rad Companion (pulmonary).
| Device ID | K183271 |
| 510k Number | K183271 |
| Device Name: | AI-Rad Companion (Pulmonary) |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Blvd. Malvern, PA 19355 |
| Contact | Kimberly Mangum |
| Correspondent | Kimberly Rendon Siemens Medical Solutions USA, Inc. 40 Liberty Blvd. Malvern, PA 19355 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-23 |
| Decision Date | 2019-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869251219 | K183271 | 000 |