SECTRA MICRODOSE MAMMOGRAPHY
Full Field Digital, System, X-ray, Mammographic
SECTRA IMTEC AB
The following data is part of a premarket notification filed by Sectra Imtec Ab with the FDA for Sectra Microdose Mammography.
Pre-market Notification Details
| Device ID | K110025 |
| 510k Number | K110025 |
| Device Name: | SECTRA MICRODOSE MAMMOGRAPHY |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | SECTRA IMTEC AB TEKNIKEINGEN 20 Linkoping, SE 58330 |
| Contact | Alexander Asklov |
| Correspondent | Alexander Asklov SECTRA IMTEC AB TEKNIKEINGEN 20 Linkoping, SE 58330 |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-03 |
| Decision Date | 2011-04-28 |
| Summary: | summary |
Trademark Results [SECTRA MICRODOSE MAMMOGRAPHY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SECTRA MICRODOSE MAMMOGRAPHY 79041268 3468207 Dead/Cancelled |
Sectra Imtec AB 2006-12-20 |
 SECTRA MICRODOSE MAMMOGRAPHY 76385028 not registered Dead/Abandoned |
Sectra Imtec AB 2002-03-20 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.