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 Applicaton Model 2010-01.
| Device ID | K100714 |
| 510k Number | K100714 |
| Device Name: | CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | CEDARS-SINAI MEDICAL CENTER 8787 SOUTHSIDE BLVD., #719 Jacksonville, FL 32256 |
| Contact | David R Dills |
| Correspondent | David R Dills CEDARS-SINAI MEDICAL CENTER 8787 SOUTHSIDE BLVD., #719 Jacksonville, FL 32256 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-12 |
| Decision Date | 2011-04-01 |
| Summary: | summary |