The following data is part of a premarket notification filed by Meridian Technique Ltd with the FDA for Orthoview 7.2.
| Device ID | K171068 |
| 510k Number | K171068 |
| Device Name: | OrthoView 7.2 |
| Classification | System, Image Processing, Radiological |
| Applicant | Meridian Technique Ltd 2 Venture Road, Southampton Science Park Southhampton, GB So16 7np |
| Contact | Barbara March |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-04-10 |
| Decision Date | 2017-10-18 |
| Summary: | summary |