The following data is part of a premarket notification filed by Casis Cardiac Simulation & Imaging Software with the FDA for Qir Suite.
| Device ID | K211611 |
| 510k Number | K211611 |
| Device Name: | QIR Suite |
| Classification | Automated Radiological Image Processing Software |
| Applicant | CASIS Cardiac Simulation & Imaging Software 7 Impasse Des Boussenots Quetigny, FR 21800 |
| Contact | Jean-Joseph Christophe |
| Correspondent | Catherine Gloster Gloster Biomedical International 577 N.Hope Ave, Suite 101 Santa Barbara, CA 93110 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-25 |
| Decision Date | 2022-09-30 |