The following data is part of a premarket notification filed by Bontech Inc. with the FDA for Bsd3543 Digital Flat Panel X-ray Detector.
| Device ID | K162487 |
| 510k Number | K162487 |
| Device Name: | BSD3543 Digital Flat Panel X-ray Detector |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | BONTECH INC. YOUNGTONG-GU YOUNGTONG-DONG 980-3, DIGITAL EMPIRE D #1201 Suwon-si, KR 443-702 |
| Contact | Kwang S. Choi |
| Correspondent | Dave Kim MTECH GROUP 8310 BUFFALO SPEEDWAY Houston, TX 77025 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-07 |
| Decision Date | 2016-10-14 |
| Summary: | summary |