Dell UP3216Q with QUBYX PerfectLum bundle
FDA 510(k) clearance K162196 · decided 2016-08-15
Clearance details
- K-number
- K162196
- Device name
- Dell UP3216Q with QUBYX PerfectLum bundle
- Applicant
- Qubyx Software Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-08-05
- Decision date
- 2016-08-15
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- PGY
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Wilmington, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.