The following data is part of a premarket notification filed by Cedars-sinai Medical Center with the FDA for Cedars-sinai Cardiac Suite Nuclear Medicine Software.
| Device ID | K123433 |
| 510k Number | K123433 |
| Device Name: | CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE |
| Classification | System, Tomography, Computed, Emission |
| Applicant | CEDARS-SINAI MEDICAL CENTER 8700 BEVERLY BOULEVARD Los Angeles, CA 90048 -1869 |
| Contact | Geoff Pollard, Program Manager |
| Correspondent | Geoff Pollard, Program Manager CEDARS-SINAI MEDICAL CENTER 8700 BEVERLY BOULEVARD Los Angeles, CA 90048 -1869 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-07 |
| Decision Date | 2013-02-26 |