The following data is part of a premarket notification filed by Pixxgen Corporation with the FDA for Pixx2430 Digital Diagnostic X-ray Receptor Panel.
| Device ID | K190691 |
| 510k Number | K190691 |
| Device Name: | Pixx2430 Digital Diagnostic X-Ray Receptor Panel |
| 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 | 2019-03-18 |
| Decision Date | 2019-04-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809378240184 | K190691 | 000 |