510(k) · Cleared
ClearedRadiForce MX315W
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 Apr 27, 2017 as substantially equivalent to K113226 (Eizo Nanao Corporation, 2011) after a 27-day review. Its family tree reaches back 4 generations to 2004. 1 later device descends from it.
- Decided
- Apr 27, 2017
- Review
- 27 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K033466 (2004). 1 later device descends from it, 1 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 backK073340 Color LCD Monitor, Flexscan MX300WEizo Nanao Corporation · 2007
- 1 generation backK113226 8MP Color LCD Monitor,Radiforce RX840Eizo Nanao Corporation · 2011
- This deviceK170949 RadiForce MX315WEizo Corporation · 2017
- Descendant · cites it directly · 0 of its ownK233465 RadiForce MX317WEizo Corporation · 2023
Most influential descendants
Showing 1 of 1 · See all- K233465RadiForce MX317WEizo Corporation · 2023 · cites it directly0descendants
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 | K073340 | Color LCD Monitor, Flexscan MX300W | Eizo Nanao Corporation | 2007 | — |
| −1 | K113226 | 8MP Color LCD Monitor,Radiforce RX840 | Eizo Nanao Corporation | 2011 | — |
| 0 (this device) | K170949 | RadiForce MX315W | Eizo Corporation | 2017 | — |
| +1 | K233465 | RadiForce MX317W | Eizo Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K113226 | 8MP Color LCD Monitor,Radiforce RX840Summary page 4…lay, Diagnostic Radiology • Regulation Number: 21 CFR 892.2050, Product Code PGY 5. Predicate Device 8MP Color LCD Monitor, RadiForce RX840 (K113226) Section 05 Traditional 510(k) Summary_MX315W: Page 1 of 5 === Page 5 =… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233465 | RadiForce MX317W | 2023 | 0 |
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 13 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K233465 (Eizo Corporation, 2023) has gone furthest, with 0 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. 2017, 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/K170949 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170949: RadiForce MX315W.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170949
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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