The following data is part of a premarket notification filed by Ziosoft, Inc. with the FDA for Cardiac Function Analysis, Calcium Scoring.
| Device ID | K083446 |
| 510k Number | K083446 |
| Device Name: | CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING |
| Classification | System, Image Processing, Radiological |
| Applicant | ZIOSOFT, INC. 1000 BRIDGE PARKWAY, SUITE 100 Redwood City, CA 94065 |
| Contact | Richard Ball |
| Correspondent | Richard Ball ZIOSOFT, INC. 1000 BRIDGE PARKWAY, SUITE 100 Redwood City, CA 94065 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-21 |
| Decision Date | 2009-03-31 |
| Summary: | summary |