510(k) · Cleared
ClearedRadiForce MX317W
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 Dec 21, 2023 as substantially equivalent to K170949 (Eizo Corporation, 2017) and 1 other predicate after a 58-day review. Its family tree reaches back 5 generations to 2004.
- Decided
- Dec 21, 2023
- Review
- 58 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K033466 (2004). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK033466 Color LCD Display, Model Radiforce R22Eizo Nanao Corporation · 2004
- 4 generations backK052344 Color LCD Monitor, Model Radioforce R31 & R31-CEizo Nanao Corporation · 2005
- 3 generations backK073340 Color LCD Monitor, Flexscan MX300WEizo Nanao Corporation · 2007
- 2 generations backK113226 8MP Color LCD Monitor,Radiforce RX840Eizo Nanao Corporation · 2011
- 1 generation backK170949 RadiForce MX315WEizo Corporation · 2017
- This deviceK233465 RadiForce MX317WEizo Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K033466 | Color LCD Display, Model Radiforce R22 | Eizo Nanao Corporation | 2004 | — |
| −4 | K052344 | Color LCD Monitor, Model Radioforce R31 & R31-C | Eizo Nanao Corporation | 2005 | — |
| −3 | K073340 | Color LCD Monitor, Flexscan MX300W | Eizo Nanao Corporation | 2007 | — |
| −2 | K113226 | 8MP Color LCD Monitor,Radiforce RX840 | Eizo Nanao Corporation | 2011 | — |
| −1 | K170949 | RadiForce MX315W | Eizo Corporation | 2017 | — |
| 0 (this device) | K233465 | RadiForce MX317W | Eizo Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K170949 | RadiForce MX315WSummary page 4…(21 CFR 892.2050) Regulatory Class: II Product Code: PGY 3. Predicate Device Name of Device: RadiForce MX315W (K170949) Common or Usual Name: 79.0 cm (31.1 inch) class Color LCD Monitor Classification Name: Display, Diagnostic Radiology… | 2017 |
| * | K113844 | Radiforce RX240Summary page 4…ic Radiology (21 CFR 892.2050) Regulatory Class: II Product Code: PGY Name of Device: RadiForce RX240 (K113844) Common or Usual Name: 2MP Color LCD Monitor Classification Name: System, Image Processing, Radiological… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 7 ancestors has a recall.
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?
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K233465 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233465: RadiForce MX317W.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233465
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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