510(k) · Cleared
Cleared3MP Color LCD Monitor, RadiForce RX350
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 Jan 12, 2016 as substantially equivalent to K113562 (Eizo Nanao Corporation, 2012) after a 53-day review. Its family tree reaches back 4 generations to 2004. 17 later devices descend from it.
- Decided
- Jan 12, 2016
- Review
- 53 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K033466 (2004). 17 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK033466 Color LCD Display, Model Radiforce R22Eizo Nanao Corporation · 2004
- 3 generations backK052344 Color LCD Monitor, Model Radioforce R31 & R31-CEizo Nanao Corporation · 2005
- 2 generations backK090045 Color LCD Monitor, Radiforce RX320Eizo Nanao Corporation · 2009
- 1 generation backK113562 3MP Color LCD Monitor, Radiforce RX340Eizo Nanao Corporation · 2012
- This deviceK153354 3MP Color LCD Monitor, RadiForce RX350Eizo Corporation · 2016
- Descendant · cites it directly · 7 of its ownK182591 RadiForce RX360, RX360-AREizo Corporation · 2018 · Recalled
- Descendant · cites it directly · 5 of its ownK191864 21HK512DLg Electronics.Inc · 2019
- Descendant · 2 generations on · 4 of its ownK212295 21HQ513DLg Electronics.Inc · 2021
- Descendant · 2 generations on · 4 of its ownK201211 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors…Shenzhen Beacon Display Technology Co., Ltd. · 2020
- Descendant · 3 generations on · 3 of its ownK223789 21HQ513DLg Electronics.Inc · 2023
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K182591RadiForce RX360, RX360-AREizo Corporation · 2018 · cites it directly7descendants
- K19186421HK512DLg Electronics.Inc · 2019 · cites it directly5descendants
- K21229521HQ513DLg Electronics.Inc · 2021 · 2 generations on4descendants
- K2012113MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+Shenzhen Beacon Display Technology Co., Ltd. · 2020 · 2 generations on4descendants
- K22378921HQ513DLg Electronics.Inc · 2023 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K033466 | Color LCD Display, Model Radiforce R22 | Eizo Nanao Corporation | 2004 | — |
| −3 | K052344 | Color LCD Monitor, Model Radioforce R31 & R31-C | Eizo Nanao Corporation | 2005 | — |
| −2 | K090045 | Color LCD Monitor, Radiforce RX320 | Eizo Nanao Corporation | 2009 | — |
| −1 | K113562 | 3MP Color LCD Monitor, Radiforce RX340 | Eizo Nanao Corporation | 2012 | — |
| 0 (this device) | K153354 | 3MP Color LCD Monitor, RadiForce RX350 | Eizo Corporation | 2016 | — |
| +1 | K182591 | RadiForce RX360, RX360-AR | Eizo Corporation | 2018 | 1 |
| +1 | K191864 | 21HK512D | Lg Electronics.Inc | 2019 | — |
| +2 | K212295 | 21HQ513D | Lg Electronics.Inc | 2021 | — |
| +2 | K201211 | 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+ | Shenzhen Beacon Display Technology Co., Ltd. | 2020 | — |
| +3 | K223789 | 21HQ513D | Lg Electronics.Inc | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 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? (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 |
|---|---|---|---|
| * | K113562 | 3MP Color LCD Monitor, Radiforce RX340Summary page 4…y, Diagnostic Radiology Regulation Number: 21 CFR 892.2050, Product Code PGY 5. Predicate Device 3MP Color LCD Monitor, RadiForce RX340 (K113562) Section 05 Traditional 510(k) Summary_RX350: Page 1 of 5 === Page 5 ==… | 2012 |
What descends from it? (17)
See all 175 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 12 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K182591 (Eizo Corporation, 2018) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K113562.
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/K153354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153354: 3MP Color LCD Monitor, RadiForce RX350.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153354
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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