The following data is part of a premarket notification filed by Cedara Software Corp. with the FDA for Cedara Webaccess, Model: 2.4.
| Device ID | K092915 |
| 510k Number | K092915 |
| Device Name: | CEDARA WEBACCESS, MODEL: 2.4 |
| Classification | System, Image Processing, Radiological |
| Applicant | CEDARA SOFTWARE CORP. 6509 AIRPORT RD. Mississauga, Ontario, CA L4v 1s7 |
| Contact | Carol Nakagawa |
| Correspondent | Carol Nakagawa CEDARA SOFTWARE CORP. 6509 AIRPORT RD. Mississauga, Ontario, CA L4v 1s7 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-22 |
| Decision Date | 2010-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842000100669 | K092915 | 000 |
| 00842000100645 | K092915 | 000 |
| 00842000100126 | K092915 | 000 |
| 00842000100683 | K092915 | 000 |
| 00842000100065 | K092915 | 000 |