510(k) · Cleared
Cleared2MP Color LCD Monitor, RadiForce RX250 and RX250-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 Feb 23, 2016 as substantially equivalent to K150106 (Eizo Corporation, 2015) after a 22-day review. Its family tree reaches back 3 generations to 2010. 4 later devices descend from it.
- Decided
- Feb 23, 2016
- Review
- 22 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K092613 (2010). 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK092613 Color LCD Monitor, Model Radiforce RS210Eizo Nanao Corporation · 2010
- 2 generations backK113844 Radiforce RX240Eizo Nanao Corporation · 2012
- 1 generation backK150106 2MP Color LCD Monitor, RadiForce RS240Eizo Corporation · 2015
- This deviceK160247 2MP Color LCD Monitor, RadiForce RX250 and RX250-AREizo Corporation · 2016
- Descendant · cites it directly · 1 of its ownK172815 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)Shenzhen Beacon Display Technology Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK253242 LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK223768 RadiForce RX270Eizo Corporation · 2023
- Descendant · cites it directly · 0 of its ownK201599 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+…Shenzhen Beacon Display Technology Co., Ltd. · 2020
Most influential descendants
Showing 4 of 4 · See all- K1728152MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)Shenzhen Beacon Display Technology Co., Ltd. · 2017 · cites it directly1descendant
- K253242LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K223768RadiForce RX270Eizo Corporation · 2023 · cites it directly0descendants
- K2015992MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+Shenzhen Beacon Display Technology Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K092613 | Color LCD Monitor, Model Radiforce RS210 | Eizo Nanao Corporation | 2010 | — |
| −2 | K113844 | Radiforce RX240 | Eizo Nanao Corporation | 2012 | — |
| −1 | K150106 | 2MP Color LCD Monitor, RadiForce RS240 | Eizo Corporation | 2015 | — |
| 0 (this device) | K160247 | 2MP Color LCD Monitor, RadiForce RX250 and RX250-AR | Eizo Corporation | 2016 | — |
| +1 | K172815 | 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) | Shenzhen Beacon Display Technology Co., Ltd. | 2017 | — |
| +2 | K253242 | LCD Monitor (C1216W, C822W, C821W) | Shenzhen Beacon Display Technology Co., Ltd. | 2025 | — |
| +1 | K223768 | RadiForce RX270 | Eizo Corporation | 2023 | — |
| +1 | K201599 | 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ | Shenzhen Beacon Display Technology Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K150106 | 2MP Color LCD Monitor, RadiForce RS240Summary page 4…y, Diagnostic Radiology • Regulation Number: 21 CFR 892.2050, Product Code PGY 5. Predicate Device • 2MP Color LCD Monitor, RadiForce RS240 (K150106) Section 05 Traditional 510(k) Summary_RX250_b: Page 1 of 5 === Page 5 ==… | 2015 |
What descends from it? (4)
3 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 6 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K172815 (Shenzhen Beacon Display Technology Co., Ltd., 2017) has gone furthest, with 1 descendant of its own.
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 for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160247: 2MP Color LCD Monitor, RadiForce RX250 and RX250-AR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160247
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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