510(k) K112474
K112474 is an FDA 510(k) premarket notification submitted by Cedars-Sinai Medical Center for the device "CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE". The FDA issued a decision of Substantially Equivalent on Sep 23, 2011. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Cedars-Sinai Medical Center has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 23, 2011
- Date Received
- Aug 26, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Tomography, Computed, Emission
- Device Class
- Class II
- Regulation Number
- 892.1200
- Review Panel
- RA
- Submission Type
- 510(k)