The following data is part of a premarket notification filed by Radisen Inc. with the FDA for Pedra-17f Digital Flat Panel X-ray Detector.
| Device ID | K180989 |
| 510k Number | K180989 |
| Device Name: | PEDRA-17F Digital Flat Panel X-ray Detector |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Radisen Inc. 14F, Gongduk B/D, 11, Saechang-ro, Mapo-gu Seoul, KR 04168 |
| Contact | John Lim |
| Correspondent | Dave Kim Mtech Group 8310 Buffalo Speedway Houston, TX 77025 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-16 |
| Decision Date | 2018-06-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800099500069 | K180989 | 000 |
| 08800099500052 | K180989 | 000 |
| 08800099500021 | K180989 | 000 |
| 08800099500014 | K180989 | 000 |
| 08800099500007 | K180989 | 000 |