The following data is part of a premarket notification filed by The Medipattern Corporation with the FDA for B-cad System, Version 1.0.
Device ID | K050846 |
510k Number | K050846 |
Device Name: | B-CAD SYSTEM, VERSION 1.0 |
Classification | System, Image Processing, Radiological |
Applicant | THE MEDIPATTERN CORPORATION 2300 SHEPPARD AVE W SUITE 204 Toronto, On, CA M9m 3a4 |
Contact | Patricia A Milbank |
Correspondent | Patricia A Milbank THE MEDIPATTERN CORPORATION 2300 SHEPPARD AVE W SUITE 204 Toronto, On, CA M9m 3a4 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-04-04 |
Decision Date | 2005-05-26 |
Summary: | summary |