The following data is part of a premarket notification filed by Jpi Healthcare Co., Ltd with the FDA for Clearvision Dr 7000f.
| Device ID | K102327 |
| 510k Number | K102327 |
| Device Name: | CLEARVISION DR 7000F |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | JPI HEALTHCARE CO., LTD 170-5 Guro-3 Dong, #608 KURO-GU Seoul, KR 152-847 |
| Contact | William Little |
| Correspondent | William Little JPI HEALTHCARE CO., LTD 170-5 Guro-3 Dong, #608 KURO-GU Seoul, KR 152-847 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-17 |
| Decision Date | 2012-04-13 |
| Summary: | summary |