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 |