The following data is part of a premarket notification filed by Siemens Healthcare Gmbh with the FDA for Ai-rad Companion (pulmonary).
| Device ID | K213713 |
| 510k Number | K213713 |
| Device Name: | AI-Rad Companion (Pulmonary) |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Siemens Healthcare GmBh 40 Liberty Blvd. Mail Code 65-1 Malvern, PA 19355 |
| Contact | Lauren Bentley |
| Correspondent | Kira Kuzmenchuk Siemens Healthcare GmBh 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 | 2021-11-24 |
| Decision Date | 2022-08-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869297279 | K213713 | 000 |
| 04056869964331 | K213713 | 000 |