The following data is part of a premarket notification filed by Change Healthcare Canada Company with the FDA for Change Healthcare Anatomical Ai.
| Device ID | K210719 |
| 510k Number | K210719 |
| Device Name: | Change Healthcare Anatomical AI |
| Classification | Automated Radiological Image Processing Software |
| Applicant | Change Healthcare Canada Company 10711 Cambie Road Richmond, CA V6x 3gs |
| Contact | Chester Mccoy |
| Correspondent | Chester Mccoy Change Healthcare Canada Company 10711 Cambie Road Richmond, CA V6x 3gs |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-10 |
| Decision Date | 2021-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17540262150018 | K210719 | 000 |