The following data is part of a premarket notification filed by Medical Imaging Applications Llc with the FDA for Vascular Tools 5, Consisting Of Brachial Analyzer 5, Carotid Analyzer 5, Vascular Imager 5 And Integrated Vascular Tools.
Device ID | K033266 |
510k Number | K033266 |
Device Name: | VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS |
Classification | Computer, Diagnostic, Programmable |
Applicant | MEDICAL IMAGING APPLICATIONS LLC 832 FOREST HILL DR Coralville, IA 52241 |
Contact | Milan Sonka |
Correspondent | Milan Sonka MEDICAL IMAGING APPLICATIONS LLC 832 FOREST HILL DR Coralville, IA 52241 |
Product Code | DQK |
CFR Regulation Number | 870.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-10-09 |
Decision Date | 2004-12-16 |
Summary: | summary |