The following data is part of a premarket notification filed by Curve Dental, Inc. with the FDA for Picture Archiving And Communications System.
| Device ID | K112974 |
| 510k Number | K112974 |
| Device Name: | PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | CURVE DENTAL, INC. 424 W. 800 N. SUITE 202 Orem, UT 84057 |
| Contact | George Stantchev |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-10-05 |
| Decision Date | 2011-10-20 |
| Summary: | summary |