510(k) · Cleared
ClearediMac 27 & PL 4.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantum-Spectra, LLC · PGY Display, Diagnostic Radiology
Cleared on Jun 2, 2020 as substantially equivalent to K171229 (Qubyx Software Technologies, Inc., 2017) after a 60-day review. Its family tree reaches back 7 generations to 2004.
- Decided
- Jun 2, 2020
- Review
- 60 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K040982 (2004). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK040982 Color LCD Monitor, Model Radiforce R12Eizo Nanao Corporation · 2004
- 6 generations backK061305 Medical Display, MDC1900-1LG (1LR)Chi Lin Technology Co., Ltd. · 2006
- 5 generations backK063579 2MP Medical Color Reference Display, Model MDC2130-2HCChi Lin Technology Co., Ltd. · 2006
- 4 generations backK083916 LCD3090WQXI or MD304MC 29.8 Inch Diagnostic Imaging LCD Monitor…Nec Display Solutions, Ltd. · 2009
- 3 generations backK111237 MD301C4 29.8 Diagnostic Imaging LCD Monitor, L309TYNec Display Solutions, Ltd. · 2011
- 2 generations backK131601 Dell U3014 with Qubyx Perfectlum BundleQubyx Limited · 2014
- 1 generation backK171229 DELL UP3017 with QUBYX PerfectLum bundleQubyx Software Technologies, Inc. · 2017
- This deviceK200889 iMac 27 & PL 4.0Quantum-Spectra, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K040982 | Color LCD Monitor, Model Radiforce R12 | Eizo Nanao Corporation | 2004 | — |
| −6 | K061305 | Medical Display, MDC1900-1LG (1LR) | Chi Lin Technology Co., Ltd. | 2006 | — |
| −5 | K063579 | 2MP Medical Color Reference Display, Model MDC2130-2HC | Chi Lin Technology Co., Ltd. | 2006 | — |
| −4 | K083916 | LCD3090WQXI or MD304MC 29.8 Inch Diagnostic Imaging LCD Monitor, Model L307TD | Nec Display Solutions, Ltd. | 2009 | — |
| −3 | K111237 | MD301C4 29.8 Diagnostic Imaging LCD Monitor, L309TY | Nec Display Solutions, Ltd. | 2011 | — |
| −2 | K131601 | Dell U3014 with Qubyx Perfectlum Bundle | Qubyx Limited | 2014 | — |
| −1 | K171229 | DELL UP3017 with QUBYX PerfectLum bundle | Qubyx Software Technologies, Inc. | 2017 | — |
| 0 (this device) | K200889 | iMac 27 & PL 4.0 | Quantum-Spectra, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
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 |
|---|---|---|---|
| * | K171229 | DELL UP3017 with QUBYX PerfectLum bundleSummary page 4…ion Name: Picture Archiving and Communications System 7.Predicate device Name: DELL UP3017 With QUBYX PerfectLum Bundle Manufacturer: DELL and QUBYX 510(k) number: K171229 Classification Number: Medical displays classified in Class II per 21 CFR 892.2050 Classification Name: Picture Archiving and C… | 2017 |
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 2.4 years on median.
- None of the 8 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. 2020, 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 Apple iMac 27" 5K Retina with PL4.0 is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners.
The device can NOT be used in mammography.
The device can NOT be used for a life-support system.
The device is intended for prescription use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200889: iMac 27 & PL 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200889
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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