The following data is part of a premarket notification filed by Confirma, Inc. with the FDA for Cadstream Version 3.1.
| Device ID | K041020 |
| 510k Number | K041020 |
| Device Name: | CADSTREAM VERSION 3.1 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| 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 | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-20 |
| Decision Date | 2004-07-07 |
| Summary: | summary |