The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Pacs Software Solution 2003.
| Device ID | K033624 |
| 510k Number | K033624 |
| Device Name: | PACS SOFTWARE SOLUTION 2003 |
| Classification | System, Image Processing, Radiological |
| Applicant | CANON U.S.A., INC. 16787 BERNARDO CENTER DRIVE SUITE A1 San Diego, CA 92128 -3616 |
| Contact | Sean M Curry |
| Correspondent | Sean M Curry CANON U.S.A., INC. 16787 BERNARDO CENTER DRIVE SUITE A1 San Diego, CA 92128 -3616 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-18 |
| Decision Date | 2003-12-15 |
| Summary: | summary |