CAPIMAGE
Camera, Scintillation (gamma)
DANISH DIAGNOSTIC DEVELOPMENT A/S
The following data is part of a premarket notification filed by Danish Diagnostic Development A/s with the FDA for Capimage.
Pre-market Notification Details
| Device ID | K081829 |
| 510k Number | K081829 |
| Device Name: | CAPIMAGE |
| Classification | Camera, Scintillation (gamma) |
| Applicant | DANISH DIAGNOSTIC DEVELOPMENT A/S DR. NEERGAARDSVEJ 5F Horsholm, DK |
| Contact | Niels Sorensen |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-06-27 |
| Decision Date | 2008-07-11 |
| Summary: | summary |
Trademark Results [CAPIMAGE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAPIMAGE 88301677 not registered Live/Pending |
SigmaSense, L.L.C. 2019-02-14 |
 CAPIMAGE 77468725 3670471 Dead/Cancelled |
Capintec, Inc. 2008-05-07 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.