510(k) · Cleared
Cleared32HL512D, 31HN713D, 32HQ713D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lg Electronics.Inc · PGY Display, Diagnostic Radiology
Cleared on Apr 27, 2023 as substantially equivalent to K192925 (Lg Electronics.Inc, 2020) and 2 other predicates after a 30-day review. Its family tree reaches back 5 generations to 2011. 2 later devices descend from it.
- Decided
- Apr 27, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K103792 (2011). 10 ancestors in all, the oldest K092613 (2010). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK103792 Barco Mammo TomosynthesisBarco N.V. · 2011
- 4 generations backK151883 5MP Monochrome LCD Monitor, RadiForce GX540Eizo Corporation · 2015
- 3 generations backK162497 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AREizo Corporation · 2016
- 2 generations backK172738 RadiForce RX560, RX560-AREizo Corporation · 2017
- 1 generation backK223423 32HQ713DLg Electronics.Inc · 2023
- This deviceK230845 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc · 2023
- Descendant · cites it directly · 1 of its ownK232127 21HQ513D, 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc · 2023
- Descendant · 2 generations on · 0 of its ownK261213 Medical Monitor (40HT513D)Lg Electronics.Inc · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K103792 | Barco Mammo Tomosynthesis | Barco N.V. | 2011 | — |
| −4 | K151883 | 5MP Monochrome LCD Monitor, RadiForce GX540 | Eizo Corporation | 2015 | — |
| −3 | K162497 | 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR | Eizo Corporation | 2016 | — |
| −2 | K172738 | RadiForce RX560, RX560-AR | Eizo Corporation | 2017 | — |
| −1 | K223423 | 32HQ713D | Lg Electronics.Inc | 2023 | — |
| 0 (this device) | K230845 | 32HL512D, 31HN713D, 32HQ713D | Lg Electronics.Inc | 2023 | — |
| +1 | K232127 | 21HQ513D, 32HL512D, 31HN713D, 32HQ713D | Lg Electronics.Inc | 2023 | — |
| +2 | K261213 | Medical Monitor (40HT513D) | Lg Electronics.Inc | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K192925 | 32HL512DSummary page 5…Predicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow; Predicate Device for 32HL512D e 510(k) Number: K192925 e Applicant: LG Electronics e (lassification Name: Medical image management and processing system e Trade Name: 32HL512D Predi… | 2020 |
| * | K201777 | 31HN713DSummary page 5…Applicant: LG Electronics e (lassification Name: Medical image management and processing system e Trade Name: 32HL512D Predicate Device for 31HN713D e 570(k) Number: K201777 e Applicant: LG Electronics e (lassification Name: Medical image management and processing system e Trade Name: 31HN713D Predi… | 2020 |
| * | K223423 | 32HQ713DSummary page 5…Applicant: LG Electronics e (lassification Name: Medical image management and processing system e Trade Name: 31HN713D Predicate Device for 32HQ713D e 510(k) Number: K223423 e Applicant: LG Electronics e (lassification Name: Medical image management and processing system e Trade Name; 32HQ713D 5. De… | 2023 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232127 | 21HQ513D, 32HL512D, 31HN713D, 32HQ713D | 2023 | 1 |
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 1.1 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K232127 (Lg Electronics.Inc, 2023) 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. 2023, 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?
32HL512D
This Medical Monitor is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
31HN713D, 32HQ713D
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K230845 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230845: 32HL512D, 31HN713D, 32HQ713D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230845
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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