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 |