510(k) · Cleared
Recalled · Class II · 2019RadiForce GX560, GX560-AR
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 Aug 24, 2018 as substantially equivalent to K162497 (Eizo Corporation, 2016) after a 66-day review. Its family tree reaches back 3 generations to 2011. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 24, 2018
- Review
- 66 days
- Class
- Class II
- Product code
- PGY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K103792 (2011). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK103792 Barco Mammo TomosynthesisBarco N.V. · 2011
- 2 generations backK151883 5MP Monochrome LCD Monitor, RadiForce GX540Eizo Corporation · 2015
- 1 generation backK162497 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AREizo Corporation · 2016
- This deviceK181609 RadiForce GX560, GX560-AREizo Corporation · 2018
- Descendant · cites it directly · 0 of its ownK252030 RadiForce GX570; RadiForce GX570-AREizo Corporation · 2025
Most influential descendants
Showing 1 of 1 · See all- K252030RadiForce GX570; RadiForce GX570-AREizo Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K103792 | Barco Mammo Tomosynthesis | Barco N.V. | 2011 | — |
| −2 | K151883 | 5MP Monochrome LCD Monitor, RadiForce GX540 | Eizo Corporation | 2015 | — |
| −1 | K162497 | 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR | Eizo Corporation | 2016 | — |
| 0 (this device) | K181609 | RadiForce GX560, GX560-AR | Eizo Corporation | 2018 | — |
| +1 | K252030 | RadiForce GX570; RadiForce GX570-AR | Eizo Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K162497 | 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-ARSummary page 4…(21 CFR 892.2050) Regulatory Class: II Product Code: PGY 3. Predicate Device EIZO Corporation RadiForce GX550, GX550-AR (K162497) Section 05 510(k) Summary_GX560_b: Page 1 of 5 4. Device De… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252030 | RadiForce GX570; RadiForce GX570-AR | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 30, 2019 | Class II | Z-2293-2020 | Device Design | Under certain conditions, a marble pattern infrequently appears on the monitor. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K252030 (Eizo Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K162497.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181609 · printed Nov 4, 2026
Cite this page
510(k) Report. “K181609: RadiForce GX560, GX560-AR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K181609
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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