The following data is part of a premarket notification filed by Pixxgen Corporation with the FDA for Prudent 1717, Prudent 1417, Prudent 1212.
| Device ID | K211108 |
| 510k Number | K211108 |
| Device Name: | Prudent 1717, Prudent 1417, Prudent 1212 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | PIXXGEN Corporation 5F, SMART BAY, 123, Beolmal-ro, Dongan-gu, Anyang-si, KR 431-804 |
| Contact | Young Kim |
| 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 | 2021-04-14 |
| Decision Date | 2021-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809378240245 | K211108 | 000 |
| 08809378240207 | K211108 | 000 |
| 08809378240191 | K211108 | 000 |