The following data is part of a premarket notification filed by Candelis, Inc. with the FDA for Imagegrid Radiology Viewer System.
| Device ID | K092949 |
| 510k Number | K092949 |
| Device Name: | IMAGEGRID RADIOLOGY VIEWER SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | CANDELIS, INC. 1600 MANCHESTER WAY Corinth, TX 76210 |
| Contact | Carl Aletto |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-09-24 |
| Decision Date | 2009-10-08 |
| Summary: | summary |