510(k) · Cleared
ClearedCL24N
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wide Corporation · PGY Display, Diagnostic Radiology
Cleared on Oct 31, 2022 as substantially equivalent to K143261 (Eizo Corporation, 2014) after a 53-day review. Its family tree reaches back 3 generations to 2010.
- Decided
- Oct 31, 2022
- Review
- 53 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K092613 (2010). No later device cites it as a predicate yet.
- Root · 3 generations backK092613 Color LCD Monitor, Model Radiforce RS210Eizo Nanao Corporation · 2010
- 2 generations backK113240 3.7 MP Color LCD Monitor, Radiforce MX270WEizo Nanao Corporation · 2012
- 1 generation backK143261 2.3MP Color LCD Monitor, RadiForce MX242WEizo Corporation · 2014
- This deviceK222717 CL24NWide Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K092613 | Color LCD Monitor, Model Radiforce RS210 | Eizo Nanao Corporation | 2010 | — |
| −2 | K113240 | 3.7 MP Color LCD Monitor, Radiforce MX270W | Eizo Nanao Corporation | 2012 | — |
| −1 | K143261 | 2.3MP Color LCD Monitor, RadiForce MX242W | Eizo Corporation | 2014 | — |
| 0 (this device) | K222717 | CL24N | Wide Corporation | 2022 | — |
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 |
|---|---|---|---|
| * | K143261 | 2.3MP Color LCD Monitor, RadiForce MX242WSummary page 4…Review Panel: Radiology 4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)] 510(k) Number: K143261 Applicant: EIZO CORPORATION Model Name: RadiForce MX242W… | 2014 |
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 12 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K143261.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The CL24N LCD Monitor System is intended to be used in displaying and viewing digital medical images for review 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/K222717 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222717: CL24N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222717
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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