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 |