510(k) · Cleared
ClearedMDMC-12133
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Barco N.V. · PGY Display, Diagnostic Radiology
Cleared on Jun 27, 2014 after a 28-day review. The FDA summary names no predicate by number. 7 later devices descend from it.
- Decided
- Jun 27, 2014
- Review
- 28 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK141428 MDMC-12133Barco N.V. · 2014
- Descendant · cites it directly · 6 of its ownK201777 31HN713DLg Electronics.Inc · 2020
- Descendant · 2 generations on · 3 of its ownK223423 32HQ713DLg Electronics.Inc · 2023
- Descendant · 2 generations on · 2 of its ownK230845 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc · 2023
- Descendant · 3 generations on · 1 of its ownK232127 21HQ513D, 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc · 2023
- Descendant · 2 generations on · 1 of its ownK221061 21HQ613DLg Electronics.Inc · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K20177731HN713DLg Electronics.Inc · 2020 · cites it directly6descendants
- K22342332HQ713DLg Electronics.Inc · 2023 · 2 generations on3descendants
- K23084532HL512D, 31HN713D, 32HQ713DLg Electronics.Inc · 2023 · 2 generations on2descendants
- K23212721HQ513D, 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc · 2023 · 3 generations on1descendant
- K22106121HQ613DLg Electronics.Inc · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K141428 | MDMC-12133 | Barco N.V. | 2014 | — |
| +1 | K201777 | 31HN713D | Lg Electronics.Inc | 2020 | — |
| +2 | K223423 | 32HQ713D | Lg Electronics.Inc | 2023 | — |
| +2 | K230845 | 32HL512D, 31HN713D, 32HQ713D | Lg Electronics.Inc | 2023 | — |
| +3 | K232127 | 21HQ513D, 32HL512D, 31HN713D, 32HQ713D | Lg Electronics.Inc | 2023 | — |
| +2 | K221061 | 21HQ613D | Lg Electronics.Inc | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 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?
The FDA summary names no predicate by number.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201777 | 31HN713D | 2020 | 6 |
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?
- Of its descendants, K201777 (Lg Electronics.Inc, 2020) has gone furthest, with 6 descendants 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. 2014, 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?
The MDMC-12133 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 especially designed for breast tomosynthesis applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141428: MDMC-12133.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141428
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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