The following data is part of a premarket notification filed by Confirma, Inc. with the FDA for Cadstream Version 4.0.
| Device ID | K043216 |
| 510k Number | K043216 |
| Device Name: | CADSTREAM VERSION 4.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | CONFIRMA, INC. 821 KIRKLAND AVE. Kirkland, WA 98033 -6318 |
| Contact | Patrica A Milbank |
| Correspondent | Patrica 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 | 2004-11-22 |
| Decision Date | 2005-01-06 |
| Summary: | summary |