The following data is part of a premarket notification filed by Omsbar Ltd with the FDA for Orthoview.
| Device ID | K032401 |
| 510k Number | K032401 |
| Device Name: | ORTHOVIEW |
| Classification | System, Image Processing, Radiological |
| Applicant | OMSBAR LTD HAWKSWORTH SOUTHMEAD INDUSTRIAL ESTATE Didcot, Oxfordshire, GB Ox11 7pl |
| Contact | Anthony Thorne |
| Correspondent | Pamela Gwynn UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-08-04 |
| Decision Date | 2003-08-14 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ORTHOVIEW 85322960 4124570 Live/Registered |
Meridian Technique Limited 2011-05-17 |
![]() ORTHOVIEW 78564205 not registered Dead/Abandoned |
OrthoClear Inc 2005-02-10 |
![]() ORTHOVIEW 76494795 not registered Dead/Abandoned |
TP Orthodontics, Inc. 2003-03-06 |
![]() ORTHOVIEW 74283815 1787926 Dead/Cancelled |
Hammon, Jensen, Wallen & Associates, Inc. 1992-06-11 |