The following data is part of a premarket notification filed by Confirma, Inc. with the FDA for Cadstream.
Device ID | K031779 |
510k Number | K031779 |
Device Name: | CADSTREAM |
Classification | System, Image Processing, Radiological |
Applicant | CONFIRMA, INC. 821 KIRKLAND AVE. Kirkland, WA 98033 -6318 |
Contact | Patricia A Milbank |
Correspondent | Patricia A Milbank CONFIRMA, INC. 821 KIRKLAND AVE. Kirkland, WA 98033 -6318 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-06-10 |
Decision Date | 2003-08-06 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CADSTREAM 78249707 2838749 Live/Registered |
MERGE HEALTHCARE SOLUTIONS INC. 2003-05-14 |