The following data is part of a premarket notification filed by Qubyx Software Technologies Inc. with the FDA for Dell Up3216q With Qubyx Perfectlum Bundle.
| Device ID | K162196 |
| 510k Number | K162196 |
| Device Name: | Dell UP3216Q With QUBYX PerfectLum Bundle |
| Classification | Display, Diagnostic Radiology |
| Applicant | QUBYX SOFTWARE TECHNOLOGIES INC. 501 SILVERSIDE ROAD, SUITE 105 Wilmington, DE 19809 |
| Contact | Marc Leppla |
| Correspondent | Marc Leppla QUBYX SOFTWARE TECHNOLOGIES INC. 501 SILVERSIDE ROAD, SUITE 105 Wilmington, DE 19809 |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-05 |
| Decision Date | 2016-08-15 |
| Summary: | summary |