The following data is part of a premarket notification filed by Cedars-sinai Medical Center with the FDA for Csmc Cardiac Suite- Nuclear Medicine Software.
| Device ID | K112474 |
| 510k Number | K112474 |
| Device Name: | CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE |
| Classification | System, Tomography, Computed, Emission |
| Applicant | CEDARS-SINAI MEDICAL CENTER 8700 BEVERLY BLVD Los Angeles, CA 90048 |
| Contact | Geoff Pollard |
| Correspondent | Geoff Pollard CEDARS-SINAI MEDICAL CENTER 8700 BEVERLY BLVD Los Angeles, CA 90048 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-26 |
| Decision Date | 2011-09-23 |