510(k) · Cleared
Cleared5MP Monochrome LCD Monitor, RadiForce GX540
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eizo Corporation · PGY Display, Diagnostic Radiology
Cleared on Jul 30, 2015 as substantially equivalent to K103792 (Barco N.V., 2011) after a 21-day review. Its family tree reaches back 1 generation to 2011. 30 later devices descend from it.
- Decided
- Jul 30, 2015
- Review
- 21 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K103792 (2011). 30 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK103792 Barco Mammo TomosynthesisBarco N.V. · 2011
- This deviceK151883 5MP Monochrome LCD Monitor, RadiForce GX540Eizo Corporation · 2015
- Descendant · cites it directly · 14 of its ownK162497 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AREizo Corporation · 2016
- Descendant · cites it directly · 12 of its ownK160326 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2…Jvckenwood Corporation · 2016
- Descendant · 2 generations on · 11 of its ownK172738 RadiForce RX560, RX560-AREizo Corporation · 2017
- Descendant · 2 generations on · 6 of its ownK191137 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500Jvckenwood Corporation · 2019
- Descendant · 3 generations on · 3 of its ownK223423 32HQ713DLg Electronics.Inc · 2023
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K1624975MP Monochrome LCD Monitor, RadiForce GX550, GX550-AREizo Corporation · 2016 · cites it directly14descendants
- K1603265MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)Jvckenwood Corporation · 2016 · cites it directly12descendants
- K172738RadiForce RX560, RX560-AREizo Corporation · 2017 · 2 generations on11descendants
- K1911375MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500Jvckenwood Corporation · 2019 · 2 generations on6descendants
- K22342332HQ713DLg Electronics.Inc · 2023 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K103792 | Barco Mammo Tomosynthesis | Barco N.V. | 2011 | — |
| 0 (this device) | K151883 | 5MP Monochrome LCD Monitor, RadiForce GX540 | Eizo Corporation | 2015 | — |
| +1 | K162497 | 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR | Eizo Corporation | 2016 | — |
| +1 | K160326 | 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) | Jvckenwood Corporation | 2016 | — |
| +2 | K172738 | RadiForce RX560, RX560-AR | Eizo Corporation | 2017 | — |
| +2 | K191137 | 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 | Jvckenwood Corporation | 2019 | — |
| +3 | K223423 | 32HQ713D | Lg Electronics.Inc | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K103792 | Barco Mammo TomosynthesisSummary page 4…mammography) 5. Predicate Device Trade/Device Name: Barco Mammo Tomosynthesis (MDMG-5221) 510(k) Number: K103792 Section 05 Traditional 510(k) Summary_GX540: Page 1 of 7… | 2011 |
What descends from it? (30)
See all 306 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162497 | 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR | 2016 | 14 |
| K160326 | 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) | 2016 | 12 |
| K152713 | 8MP Color LCD Monitor, RadiForce RX850, RX850-AR | 2015 | 1 |
| K252030 | RadiForce GX570; RadiForce GX570-AR | 2025 | 0 |
| K243221 | RadiForce RX570; RadiForce RX570-AR | 2024 | 0 |
| K160328 | DIVA ZSP2105CMI with QUBYX PerfectLum bundle | 2016 | 0 |
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?
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?
This product is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151883 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151883: 5MP Monochrome LCD Monitor, RadiForce GX540.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151883
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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