510(k) · Cleared
ClearedDell UP3216Q with QUBYX PerfectLum bundle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qubyx Software Technologies, Inc. · PGY Display, Diagnostic Radiology
Cleared on Aug 15, 2016 as substantially equivalent to K150145 (Nec Display Solutions, Ltd., 2015) after a 10-day review. Its family tree reaches back 10 generations to 2000.
- Decided
- Aug 15, 2016
- Review
- 10 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K000293 (2000). No later device cites it as a predicate yet.
- Root · 10 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
- 6 generations between
- 3 generations backK130770 MD211C3 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2013
- 2 generations backK142951 MD210C3 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2014
- 1 generation backK150145 MD322C8 31.5 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2015
- This deviceK162196 Dell UP3216Q with QUBYX PerfectLum bundleQubyx Software Technologies, Inc. · 2016
Show all 10 generations
- Root · 10 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
- 9 generations backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
- 8 generations backK022109 Eizo, Model FC-2091Eizo Nanao Corporation · 2002
- 7 generations backK041597 Monochrome LCD Monitor, Model Radiforce G22Eizo Nanao Corporation · 2004
- 6 generations backK061303 Medical Display, Models MDM 1900-1NG and MDM 1900-1NRChi Lin Technology Co., Ltd. · 2006
- 5 generations backK063266 3MP Medical Monochrome Reference Display, Model MDM2130-3NCChi Lin Technology Co., Ltd. · 2006
- 4 generations backK090215 MD213MG 21.3 Diagnostic Imaging LCD Monitor - L218TLNec Display Solutions, Ltd. · 2009
- 3 generations backK130770 MD211C3 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2013
- 2 generations backK142951 MD210C3 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2014
- 1 generation backK150145 MD322C8 31.5 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2015
- This deviceK162196 Dell UP3216Q with QUBYX PerfectLum bundleQubyx Software Technologies, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K000293 | Barco MGD 221 2 Megapixel Diagnostic Display | Barco N.V. | 2000 | — |
| −9 | K012099 | Monochrome Perfectly Flat Panel Displays, ME Series | Totoku Electric Co., Ltd. | 2001 | — |
| −8 | K022109 | Eizo, Model FC-2091 | Eizo Nanao Corporation | 2002 | — |
| −7 | K041597 | Monochrome LCD Monitor, Model Radiforce G22 | Eizo Nanao Corporation | 2004 | — |
| −6 | K061303 | Medical Display, Models MDM 1900-1NG and MDM 1900-1NR | Chi Lin Technology Co., Ltd. | 2006 | — |
| −5 | K063266 | 3MP Medical Monochrome Reference Display, Model MDM2130-3NC | Chi Lin Technology Co., Ltd. | 2006 | — |
| −4 | K090215 | MD213MG 21.3 Diagnostic Imaging LCD Monitor - L218TL | Nec Display Solutions, Ltd. | 2009 | — |
| −3 | K130770 | MD211C3 21.3 Diagnostic Imaging LCD Monitor | Nec Display Solutions, Ltd. | 2013 | — |
| −2 | K142951 | MD210C3 21.3 Diagnostic Imaging LCD Monitor | Nec Display Solutions, Ltd. | 2014 | — |
| −1 | K150145 | MD322C8 31.5 Diagnostic Imaging LCD Monitor | Nec Display Solutions, Ltd. | 2015 | — |
| 0 (this device) | K162196 | Dell UP3216Q with QUBYX PerfectLum bundle | Qubyx Software Technologies, Inc. | 2016 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PGY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PGY device
- #1 K261213 Medical Monitor (40HT513D)score 13.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150145 | MD322C8 31.5 Diagnostic Imaging LCD MonitorSummary page 4…er Medical displays classified in Class II per 21 CFR 892.2050 7. Predicate device 1 Name: NEC MultiSync MD322C8 Manufacturer: NEC Display Solutions Inc. 510(k) number: K150145 8. Device description The DELL UP3216Q with QUBYX PerfectLum is a 31.5” color display for medical viewing. It provides 3840x2… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- None of the 10 ancestors has a recall.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PGY
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PGY
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PGY
No recall names PGY since 2007.
Adverse event reports per year · PGY
1in 2017
MAUDE reports naming product code PGY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 14 | 24 | 0 | 0 |
| 2015 | 16 | 31 | 0 | 0 |
| 2016 | 18 | 27 | 0 | 0 |
| 2017 | 11 | 30 | 0 | 1 |
| 2018 | 5 | 28 | 0 | 0 |
| 2019 | 11 | 58 | 0 | 0 |
| 2020 | 12 | 61 | 0 | 0 |
| 2021 | 7 | 77 | 0 | 0 |
| 2022 | 10 | 60 | 0 | 0 |
| 2023 | 17 | 60 | 0 | 0 |
| 2024 | 10 | 53 | 0 | 0 |
| 2025 | 3 | 59 | 0 | 0 |
| 2026 | 4 | 48 | 0 | — |
What is it indicated for?
The DELL UP3216Q with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for
review and analysis by trained medical practitioners.
The DELL UP3216Q can be used only in conjunction with QUBYX PerfectLum.
The device can not be used in primary image diagnosis in mammography.
The device can not be used for a life-support system.
The device does not contact with the patient.
The device is intended for prescription use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162196: Dell UP3216Q with QUBYX PerfectLum bundle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162196
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026