510(k) Report

510(k) · Cleared

Cleared

32HQ713D

K223423510(k) TraditionalCleared Mar 1, 2023107-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

Lg Electronics.Inc · PGY Display, Diagnostic Radiology

Cleared on Mar 1, 2023 as substantially equivalent to K172738 (Eizo Corporation, 2017) and 1 other predicate after a 107-day review. Its family tree reaches back 4 generations to 2011. 3 later devices descend from it.

Decided
Mar 1, 2023
Review
107 days
Class
Class II
Product code
PGY
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K103792 (2011). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2020: 1 other ancestor2014: 1 other ancestor2023: 2 descendants cleared2026: 1 descendant clearedK103792 · Barco Mammo Tomosynthesis · Barco N.V. · 2011K151883 · 5MP Monochrome LCD Monitor, RadiForce GX540 · Eizo Corporation · 2015K162497 · 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR · Eizo Corporation · 2016K172738 · RadiForce RX560, RX560-AR · Eizo Corporation · 20172010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K172738 · RadiForce RX560, RX560-AR · Eizo Corporation · 2017K162497 · 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR · Eizo Corporation · 2016K151883 · 5MP Monochrome LCD Monitor, RadiForce GX540 · Eizo Corporation · 2015K103792 · Barco Mammo Tomosynthesis · Barco N.V. · 20110
  1. Root · 4 generations backK103792 Barco Mammo TomosynthesisBarco N.V. · 2011
  2. 3 generations backK151883 5MP Monochrome LCD Monitor, RadiForce GX540Eizo Corporation · 2015
  3. 2 generations backK162497 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AREizo Corporation · 2016
  4. 1 generation backK172738 RadiForce RX560, RX560-AREizo Corporation · 2017
  5. This deviceK223423 32HQ713DLg Electronics.Inc · 2023
  6. Descendant · cites it directly · 2 of its ownK230845 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc · 2023
  7. Descendant · 2 generations on · 1 of its ownK232127 21HQ513D, 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc · 2023
  8. Descendant · 3 generations on · 0 of its ownK261213 Medical Monitor (40HT513D)Lg Electronics.Inc · 2026

Most influential descendants

Showing 3 of 3 · See all
  • K23084532HL512D, 31HN713D, 32HQ713DLg Electronics.Inc · 2023 · cites it directly2descendants
  • K23212721HQ513D, 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc · 2023 · 2 generations on1descendant
  • K261213Medical Monitor (40HT513D)Lg Electronics.Inc · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K103792Barco Mammo TomosynthesisBarco N.V.2011—
−3K1518835MP Monochrome LCD Monitor, RadiForce GX540Eizo Corporation2015—
−2K1624975MP Monochrome LCD Monitor, RadiForce GX550, GX550-AREizo Corporation2016—
−1K172738RadiForce RX560, RX560-AREizo Corporation2017—
0 (this device)K22342332HQ713DLg Electronics.Inc2023—
+1K23084532HL512D, 31HN713D, 32HQ713DLg Electronics.Inc2023—
+2K23212721HQ513D, 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc2023—
+3K261213Medical Monitor (40HT513D)Lg Electronics.Inc2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201410
202010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202320
202610
FIG. 1 — Lineage of K223423, 2011–2026Source: 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
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What was it cleared against? (2)

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
*K172738RadiForce RX560, RX560-AR
Summary page 5
…R 807.92(a)(3)] The identified predicate devices within this submission are shown as follow; Primary Predicate Device ⚫ 510(k) Number: K172738 ⚫ Applicant: EIZO Corporation ⚫ Classification Name: Picture archiving an…
Eizo Corporation2017—
*K20177731HN713D
Summary page 5
…Picture archiving and communications system ⚫ Trade Name: RX560 Predicate Device ⚫ 510(k) Number: K201777 ⚫ Applicant: LG Electronics ⚫ Classification Name: Picture archiving and…
Lg Electronics.Inc2020—

Also cleared against K172738: 3 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K23084532HL512D, 31HN713D, 32HQ713DLg Electronics.Inc20232

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 12 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K230845 (Lg Electronics.Inc, 2023) has gone furthest, with 2 descendants of its own.
  • 3 other devices also cite its predicate K172738.

How does its category compare?

All PGY devices

PGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Medical Monitor 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.

Cite this page

510(k) Report. “K223423: 32HQ713D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223423

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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