The following data is part of a premarket notification filed by Confirma, Inc. with the FDA for Cadstream Version 5.
| Device ID | K092954 |
| 510k Number | K092954 |
| Device Name: | CADSTREAM VERSION 5 |
| Classification | System, Image Processing, Radiological |
| Applicant | CONFIRMA, INC. 11040 MAIN STREET SUITE 100 Bellevue, WA 98004 |
| Contact | Brent Lewis |
| Correspondent | Brent Lewis CONFIRMA, INC. 11040 MAIN STREET SUITE 100 Bellevue, WA 98004 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-25 |
| Decision Date | 2009-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842000100638 | K092954 | 000 |
| 00842000100881 | K092954 | 000 |
| 00842000101031 | K092954 | 000 |
| 00842000100003 | K092954 | 000 |
| 00842000101116 | K092954 | 000 |