The following data is part of a premarket notification filed by Jpi Healthcare Co., Ltd with the FDA for Clearvision Dr 2000 Digital Radiography X-ray System.
| Device ID | K101779 |
| 510k Number | K101779 |
| Device Name: | CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM |
| Classification | System, X-ray, Stationary |
| 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 | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-25 |
| Decision Date | 2011-05-16 |
| Summary: | summary |