510(k) Report

510(k) · Cleared

Cleared

2MP Color LCD Monitor, RadiForce RS240

K150106510(k) TraditionalCleared Apr 3, 201573-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Eizo Corporation · PGY Display, Diagnostic Radiology

Cleared on Apr 3, 2015 as substantially equivalent to K113844 (Eizo Nanao Corporation, 2012) after a 73-day review. Its family tree reaches back 2 generations to 2010. 5 later devices descend from it.

Decided
Apr 3, 2015
Review
73 days
Class
Class II
Product code
PGY
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K092613 (2010). 5 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2017: 1 descendant cleared2023: 1 descendant cleared2020: 1 descendant cleared2025: 1 descendant clearedK092613 · Color LCD Monitor, Model Radiforce RS210 · Eizo Nanao Corporation · 2010K113844 · Radiforce RX240 · Eizo Nanao Corporation · 20122010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 1 descendant K113844 · Radiforce RX240 · Eizo Nanao Corporation · 2012K092613 · Color LCD Monitor, Model Radiforce RS210 · Eizo Nanao Corporation · 20100
  1. Root · 2 generations backK092613 Color LCD Monitor, Model Radiforce RS210Eizo Nanao Corporation · 2010
  2. 1 generation backK113844 Radiforce RX240Eizo Nanao Corporation · 2012
  3. This deviceK150106 2MP Color LCD Monitor, RadiForce RS240Eizo Corporation · 2015
  4. Descendant · cites it directly · 4 of its ownK160247 2MP Color LCD Monitor, RadiForce RX250 and RX250-AREizo Corporation · 2016
  5. Descendant · 2 generations on · 1 of its ownK172815 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)Shenzhen Beacon Display Technology Co., Ltd. · 2017
  6. Descendant · 3 generations on · 0 of its ownK253242 LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd. · 2025
  7. Descendant · 2 generations on · 0 of its ownK223768 RadiForce RX270Eizo Corporation · 2023
  8. Descendant · 2 generations on · 0 of its ownK201599 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+…Shenzhen Beacon Display Technology Co., Ltd. · 2020

Most influential descendants

Showing 5 of 5 · See all
  • K1602472MP Color LCD Monitor, RadiForce RX250 and RX250-AREizo Corporation · 2016 · cites it directly4descendants
  • K1728152MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)Shenzhen Beacon Display Technology Co., Ltd. · 2017 · 2 generations on1descendant
  • K253242LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd. · 2025 · 3 generations on0descendants
  • K223768RadiForce RX270Eizo Corporation · 2023 · 2 generations on0descendants
  • K2015992MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+Shenzhen Beacon Display Technology Co., Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K092613Color LCD Monitor, Model Radiforce RS210Eizo Nanao Corporation2010—
−1K113844Radiforce RX240Eizo Nanao Corporation2012—
0 (this device)K1501062MP Color LCD Monitor, RadiForce RS240Eizo Corporation2015—
+1K1602472MP Color LCD Monitor, RadiForce RX250 and RX250-AREizo Corporation2016—
+2K1728152MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)Shenzhen Beacon Display Technology Co., Ltd.2017—
+3K253242LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd.2025—
+2K223768RadiForce RX270Eizo Corporation2023—
+2K2015992MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+Shenzhen Beacon Display Technology Co., Ltd.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201710
202010
202310
202510
FIG. 1 — Lineage of K150106, 2010–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261213 Medical Monitor (40HT513D)score 13.9 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K113844Radiforce RX240
Summary page 4
…y, Diagnostic Radiology  Regulation Number: 21 CFR 892.2050, Product Code PGY 5. Predicate Device  2MP Color LCD Monitor, RadiForce RX240 (K113844) Section 05 Traditional 510(k) Summary_RS240: Page 1 of 5 === Page 5 ==…
Eizo Nanao Corporation2012—

Also cleared against K113844: 2 other devices →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K1602472MP Color LCD Monitor, RadiForce RX250 and RX250-AREizo Corporation20164

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 3.1 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K160247 (Eizo Corporation, 2016) has gone furthest, with 4 descendants of its own.
  • 2 other devices also cite its predicate K113844.

How does its category compare?

All PGY devices

PGY 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

2014: 142015: 162016: 182017: 112018: 52019: 112020: 122021: 72022: 102023: 172024: 102025: 32026 (partial year): 4
2007high 18 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PGY

59in 2025

2014: 24 days median2015: 31 days median2016: 27 days median2017: 30 days median2018: 28 days median2019: 58 days median2020: 61 days median2021: 77 days median2022: 60 days median2023: 60 days median2024: 53 days median2025: 59 days median2026 (partial year): 48 days median
2007high 77 (2021) · low 24 (2014)2026

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

2017: 1
2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code PGY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
2014142400
2015163100
2016182700
2017113001
201852800
2019115800
2020126100
202177700
2022106000
2023176000
2024105300
202535900
20264480—

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.

Cite this page

510(k) Report. “K150106: 2MP Color LCD Monitor, RadiForce RS240.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150106

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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