K083446 is an FDA 510(k) clearance for the CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Ziosoft, Inc. (Redwood City, US). The FDA issued a Cleared decision on March 31, 2009, 130 days after receiving the submission on November 21, 2008.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K083446 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2008 |
| Decision Date | March 31, 2009 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |