510(k) · Cleared
ClearedRadiForce MX317W-PA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eizo Corporation · PZZ Digital Pathology Display
Cleared on May 23, 2025 as substantially equivalent to K203364 (Barco N.V., 2021) after a 269-day review. Its family tree reaches back 4 generations to 2017.
- Decided
- May 23, 2025
- Review
- 269 days
- Class
- Class II
- Product code
- PZZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN160056 (2017). No later device cites it as a predicate yet.
- Root · 4 generations backDEN160056 Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2017
- 3 generations backK172174 Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2017
- 2 generations backK192259 Philips IntelliSite Pathology SolutionPhilips Electronics Nederland B.V. · 2019
- 1 generation backK203364 MDPC-8127Barco N.V. · 2021
- This deviceK242545 RadiForce MX317W-PAEizo Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN160056 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2017 | — |
| −3 | K172174 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2017 | — |
| −2 | K192259 | Philips IntelliSite Pathology Solution | Philips Electronics Nederland B.V. | 2019 | — |
| −1 | K203364 | MDPC-8127 | Barco N.V. | 2021 | — |
| 0 (this device) | K242545 | RadiForce MX317W-PA | Eizo Corporation | 2025 | — |
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 PZZ? 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 PZZ device
- #1 K233119 8MP Color LCD Displays C811W, C811WT, PA27 and…score 9.2 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K203364 | MDPC-8127Summary page 5…stem (21 CFR 864.3700) • Regulatory Class: II • Product Code: PZZ 3. Predicate Device • Name of Device: MDPC-8127 (K203364) • Common or Usual Name: Digital Pathology Display • Classification Name: Whole Slide Imaging System… | 2021 |
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 8 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All PZZ devicesPZZ Digital Pathology Display: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PZZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PZZ
Too few PZZ 510(k)s in any year since 2007 to give a median.
Recalls per year · PZZ
No recall names PZZ since 2007.
Adverse event reports per year · PZZ
No MAUDE report names PZZ since 2007.
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 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
RadiForce MX317W-PA is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital pathology image viewing software that have been validated for use with this device. RadiForce MX317W-PA is an aid to the pathologist and is used for review and interpretation of histopathology slides for the purposes of primary diagnosis. It is the…
Read the full statement (111 words)
RadiForce MX317W-PA is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital pathology image viewing software that have been validated for use with this device.
RadiForce MX317W-PA is an aid to the pathologist and is used for review and interpretation of histopathology slides for the purposes of primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using this product. The display is not intended for use with digital images from frozen section, cytology, or non- formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242545 · printed Nov 3, 2026
Cite this page
510(k) Report. “K242545: RadiForce MX317W-PA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K242545
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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