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 |
---|---|---|
B021751WEBWK0 | 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 |
B021706WEBWK0 | K063327 | 000 |
B021702WEBWK0 | K063327 | 000 |
B02174WEBWK0 | K063327 | 000 |
B021741WEBWK0 | 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 |
B021733WINAN0 | 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 |