The following data is part of a premarket notification filed by Merdian Technique, Ltd. with the FDA for Orthoview.
| Device ID | K063327 |
| 510k Number | K063327 |
| Device Name: | ORTHOVIEW |
| Classification | System, Image Processing, Radiological |
| Applicant | MERDIAN TECHNIQUE, LTD. UNIT 7 BUILDING T2, AREA 200 Milton Park, Abingdon, GB Ox14 4ta |
| Contact | Anthony Thorne |
| Correspondent | Neil E Devine, Jr. INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-11-03 |
| Decision Date | 2006-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060687387516 | K063327 | 000 |
| B021702WEBWK0 | K063327 | 000 |
| B021702WINIAR0 | K063327 | 000 |
| B021702WINIDC0 | K063327 | 000 |
| B021702WININD0 | K063327 | 000 |
| B021702WINWK0 | K063327 | 000 |
| B021702WINWK70 | K063327 | 000 |
| B021703WINELO0 | K063327 | 000 |
| B021703WINRSH0 | K063327 | 000 |
| B021704WINISD0 | K063327 | 000 |
| B021705WEBIPX0 | K063327 | 000 |
| B02174WEBWK0 | K063327 | 000 |
| B021741WEBWK0 | K063327 | 000 |
| B021733WINAN0 | K063327 | 000 |
| B021751WEBWK0 | K063327 | 000 |
| B021751WINWK0 | K063327 | 000 |
| B0217502WEBWK0 | K063327 | 000 |
| B02175WINIAR0 | K063327 | 000 |
| B02175WEBWK0 | K063327 | 000 |
| B02175WINWK0 | K063327 | 000 |
| B021747WEBWK0 | K063327 | 000 |
| B021746WEBWK0 | K063327 | 000 |
| B021734WININD0 | K063327 | 000 |
| B021744WEBWK0 | K063327 | 000 |
| B021706WEBWK0 | K063327 | 000 |
| B021711WEBWK0 | K063327 | 000 |
| B021711WINWK0 | K063327 | 000 |
| B021731WINISD0 | K063327 | 000 |
| B021731WINWK0 | K063327 | 000 |
| B021732WEBIDC0 | K063327 | 000 |
| B021732WEBWK0 | K063327 | 000 |
| B021732WINIDC0 | K063327 | 000 |
| B02173MACWK0 | K063327 | 000 |
| B02173WEBIPX0 | K063327 | 000 |
| B02173WEBWK0 | K063327 | 000 |
| B02173WINDM7 | K063327 | 000 |
| B02173WINWK0 | K063327 | 000 |
| B02171WINWK70 | K063327 | 000 |
| B021715WINIDC0 | K063327 | 000 |
| B021715WEBWK0 | K063327 | 000 |
| B021712WEBELO0 | K063327 | 000 |
| B021712WEBWK0 | K063327 | 000 |
| B021712WINWK0 | K063327 | 000 |
| B021712WINWK70 | K063327 | 000 |
| B021713WEBWK0 | K063327 | 000 |
| B021713WINWK0 | K063327 | 000 |
| B021714WEBMW0 | K063327 | 000 |
| B021714WEBWK0 | K063327 | 000 |
| B021714WINDM70 | K063327 | 000 |
| B021714WINWK0 | K063327 | 000 |
| B02173WINWK70 | K063327 | 000 |
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 |