The following data is part of a premarket notification filed by Jpi Healthcare, Inc with the FDA for Clearvision Examvue Flat Panel Detector.
| Device ID | K160143 |
| 510k Number | K160143 |
| Device Name: | ClearVision ExamVue Flat Panel Detector |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | JPI HEALTHCARE, INC WOOLIM E-BIZ CENTER #608, 170-5 Kuro 3-dong, Kuro-gu, KR 152-769 |
| Contact | Jang Won Lee |
| Correspondent | William Little JPI Healthcare Solutions, Inc 52 Newtown Plaza Plainview, NY 11803 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-21 |
| Decision Date | 2016-10-28 |
| Summary: | summary |