The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Cardiq Suite.
| Device ID | K213725 |
| 510k Number | K213725 |
| Device Name: | CardIQ Suite |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE Medical Systems SCS 283, Rue De La Miniere Buc, FR 78530 |
| Contact | Yonghui Han |
| Correspondent | Yonghui Han GE Medical Systems SCS 283, Rue De La Miniere Buc, FR 78530 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-26 |
| Decision Date | 2022-03-11 |