The following data is part of a premarket notification filed by Pixxgen Corporation with the FDA for Pixx 1717; Pixx 1417; Pixx 1212; Digital Diagnostic X-ray Receptor Panels.
| Device ID | K180976 |
| 510k Number | K180976 |
| Device Name: | PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Pixxgen Corporation 5F SMART BAY, 123, Beolmal-ro, Dongan-gu Anyang-si, KR 14056 |
| Contact | John Ross |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-13 |
| Decision Date | 2018-05-24 |
| Summary: | summary |