The following data is part of a premarket notification filed by Clearcanvas Inc. with the FDA for Clearcanvas Ris / Pacs.
| Device ID | K110332 |
| 510k Number | K110332 |
| Device Name: | CLEARCANVAS RIS / PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | CLEARCANVAS INC. 439 UNIVERSITY AVE. SUITE 1920 Toronto, On, CA M5g 1y8 |
| Contact | Clinton Chau |
| Correspondent | Paula Wilkerson INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-02-03 |
| Decision Date | 2011-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00670082000139 | K110332 | 000 |