510(k) · Cleared
Cleared5MP Monochrome LCD Monitor, RadiForce GX550, GX550-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 Sep 19, 2016 as substantially equivalent to K151883 (Eizo Corporation, 2015) after a 12-day review. Its family tree reaches back 2 generations to 2011. 14 later devices descend from it.
- Decided
- Sep 19, 2016
- Review
- 12 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K103792 (2011). 14 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK103792 Barco Mammo TomosynthesisBarco N.V. · 2011
- 1 generation backK151883 5MP Monochrome LCD Monitor, RadiForce GX540Eizo Corporation · 2015
- This deviceK162497 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AREizo Corporation · 2016
- Descendant · cites it directly · 11 of its ownK172738 RadiForce RX560, RX560-AREizo Corporation · 2017
- Descendant · 2 generations on · 3 of its ownK223423 32HQ713DLg Electronics.Inc · 2023
- Descendant · 2 generations on · 3 of its ownK200485 RadiForce RX1270, RadiForce RX1270-AREizo Corporation · 2020
- Descendant · 3 generations on · 2 of its ownK230845 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc · 2023
- Descendant · 3 generations on · 1 of its ownK231026 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank…Shenzhen Beacon Display Technology Co., Ltd. · 2023
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K172738RadiForce RX560, RX560-AREizo Corporation · 2017 · cites it directly11descendants
- K22342332HQ713DLg Electronics.Inc · 2023 · 2 generations on3descendants
- K200485RadiForce RX1270, RadiForce RX1270-AREizo Corporation · 2020 · 2 generations on3descendants
- K23084532HL512D, 31HN713D, 32HQ713DLg Electronics.Inc · 2023 · 3 generations on2descendants
- K23102612MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference…Shenzhen Beacon Display Technology Co., Ltd. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K103792 | Barco Mammo Tomosynthesis | Barco N.V. | 2011 | — |
| −1 | K151883 | 5MP Monochrome LCD Monitor, RadiForce GX540 | Eizo Corporation | 2015 | — |
| 0 (this device) | K162497 | 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR | Eizo Corporation | 2016 | — |
| +1 | K172738 | RadiForce RX560, RX560-AR | Eizo Corporation | 2017 | — |
| +2 | K223423 | 32HQ713D | Lg Electronics.Inc | 2023 | — |
| +2 | K200485 | RadiForce RX1270, RadiForce RX1270-AR | Eizo Corporation | 2020 | — |
| +3 | K230845 | 32HL512D, 31HN713D, 32HQ713D | Lg Electronics.Inc | 2023 | — |
| +3 | K231026 | 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the… | Shenzhen Beacon Display Technology Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K151883 | 5MP Monochrome LCD Monitor, RadiForce GX540Summary page 4…agnostic Radiology Regulation Number: 21 CFR 892.2050, Product Code PGY 5. Predicate Device 5MP Monochrome LCD Monitor, RadiForce GX540 (K151883) Section 05 Traditional 510(k) Summary_GX550: Page 1 of 6 === Page 5 ==… | 2015 |
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K172738 (Eizo Corporation, 2017) has gone furthest, with 11 descendants of its own.
- 5 other devices also cite its predicate K151883.
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?
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/K162497 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162497: 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162497
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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