510(k) · Cleared
ClearedDIVA ZSP5812CMI with QUBYX PerfectLum bundle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qubyx, Ltd. · PGY Display, Diagnostic Radiology
Cleared on Nov 17, 2015 as substantially equivalent to K134002 (Eizo Corporation, 2014) after a 49-day review. Its family tree reaches back 5 generations to 2004.
- Decided
- Nov 17, 2015
- Review
- 49 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K033466 (2004). No later device cites it as a predicate yet.
- Root · 5 generations backK033466 Color LCD Display, Model Radiforce R22Eizo Nanao Corporation · 2004
- 4 generations backK052344 Color LCD Monitor, Model Radioforce R31 & R31-CEizo Nanao Corporation · 2005
- 3 generations backK090045 Color LCD Monitor, Radiforce RX320Eizo Nanao Corporation · 2009
- 2 generations backK113562 3MP Color LCD Monitor, Radiforce RX340Eizo Nanao Corporation · 2012
- 1 generation backK134002 6MP Color LCD Monitor, Radiforce RX650Eizo Corporation · 2014 · Recalled
- This deviceK152847 DIVA ZSP5812CMI with QUBYX PerfectLum bundleQubyx, Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K033466 | Color LCD Display, Model Radiforce R22 | Eizo Nanao Corporation | 2004 | — |
| −4 | K052344 | Color LCD Monitor, Model Radioforce R31 & R31-C | Eizo Nanao Corporation | 2005 | — |
| −3 | K090045 | Color LCD Monitor, Radiforce RX320 | Eizo Nanao Corporation | 2009 | — |
| −2 | K113562 | 3MP Color LCD Monitor, Radiforce RX340 | Eizo Nanao Corporation | 2012 | — |
| −1 | K134002 | 6MP Color LCD Monitor, Radiforce RX650 | Eizo Corporation | 2014 | 1 |
| 0 (this device) | K152847 | DIVA ZSP5812CMI with QUBYX PerfectLum bundle | Qubyx, Ltd. | 2015 | — |
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 |
|---|---|---|---|
| * | K134002 | 6MP Color LCD Monitor, Radiforce RX650Summary page 4…ation Number Medical displays classified in Class II per 21 CFR 892.2050 7. Predicate device 1 Name: EIZO RadiForce RX650 Manufacturer: EIZO Corporation 510(k) number: K134002 8. Device description The DIVA ZSP5812CMI with QUBYX PerfectLum is a 58" color display for medical viewing. It is combined wi… | 2014 |
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 11 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 3 other devices also cite its predicate K134002.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 DIVA ZSP5812CMI with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners.
The DIVA ZSP5812CMI 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152847: DIVA ZSP5812CMI 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/K152847
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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