The following data is part of a premarket notification filed by Curve Dental Ltd with the FDA for Curve Image 2.0 Pacs.
| Device ID | K173101 |
| 510k Number | K173101 |
| Device Name: | Curve Image 2.0 PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | Curve Dental LTD Suite 240, 2912 Memorial Dr. SE Calgary, CA T2a6r1 |
| Contact | Raul Nemes |
| Correspondent | Raul Nemes Curve Dental LTD Suite 240, 2912 Memorial Dr. SE Calgary, CA T2a6r1 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2017-10-18 |