IMAGEGRID
System, Image Processing, Radiological
CANDELIS, INC.
The following data is part of a premarket notification filed by Candelis, Inc. with the FDA for Imagegrid.
Pre-market Notification Details
| Device ID | K080333 |
| 510k Number | K080333 |
| Device Name: | IMAGEGRID |
| Classification | System, Image Processing, Radiological |
| Applicant | CANDELIS, INC. 1600 MANCHESTER WAY Corinth, TX 76210 |
| Contact | Carl Alletto |
| 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 | 2008-02-07 |
| Decision Date | 2008-02-22 |
| Summary: | summary |
Trademark Results [IMAGEGRID]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IMAGEGRID 78564818 3525691 Live/Registered |
CANDELIS, INC. 2005-02-10 |
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