510(k) · Cleared
ClearedRadiForce MX216
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 Mar 8, 2019 as substantially equivalent to K131090 (Eizo Corporation, 2013) after a 37-day review. Its family tree reaches back 2 generations to 2010. 2 later devices descend from it.
- Decided
- Mar 8, 2019
- Review
- 37 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K092613 (2010). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK092613 Color LCD Monitor, Model Radiforce RS210Eizo Nanao Corporation · 2010
- 1 generation backK131090 2MP Color LCD Monitor, Radiforce MX215Eizo Corporation · 2013
- This deviceK190153 RadiForce MX216Eizo Corporation · 2019
- Descendant · cites it directly · 1 of its ownK230684 RadiForce MX217Eizo Corporation · 2023
- Descendant · 2 generations on · 0 of its ownK252780 LCD Monitor (CL1902A, CL2103F)Shenzhen Beacon Display Technology Co., Ltd. · 2025
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 |
|---|---|---|---|---|---|
| −2 | K092613 | Color LCD Monitor, Model Radiforce RS210 | Eizo Nanao Corporation | 2010 | — |
| −1 | K131090 | 2MP Color LCD Monitor, Radiforce MX215 | Eizo Corporation | 2013 | — |
| 0 (this device) | K190153 | RadiForce MX216 | Eizo Corporation | 2019 | — |
| +1 | K230684 | RadiForce MX217 | Eizo Corporation | 2023 | — |
| +2 | K252780 | LCD Monitor (CL1902A, CL2103F) | Shenzhen Beacon Display Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K131090 | 2MP Color LCD Monitor, Radiforce MX215Summary page 4…(21 CFR 892.2050) • Regulatory Class: II • Product Code: PGY 3. Predicate Device EIZO Corporation RadiForce MX215 (K131090) Section 05 510(k) Summary_MX216: Page 1 of 4 4.… | 2013 |
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 |
|---|---|---|---|
| K230684 | RadiForce MX217 | 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 9 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K230684 (Eizo Corporation, 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K131090.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190153 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190153: RadiForce MX216.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190153
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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