510(k) · Cleared
ClearedJUSHA-M23C LCD Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanjing Jusha Display Technology Co., Ltd. · PGY Display, Diagnostic Radiology
Cleared on Jun 12, 2015 as substantially equivalent to K120407 (Eizo Nanao Corporation, 2012) after a 32-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Jun 12, 2015
- Review
- 32 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K000293 (2000). No later device cites it as a predicate yet.
- Root · 6 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
- 5 generations backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
- 4 generations backK022109 Eizo, Model FC-2091Eizo Nanao Corporation · 2002
- 3 generations backK041597 Monochrome LCD Monitor, Model Radiforce G22Eizo Nanao Corporation · 2004
- 2 generations backK070131 Radiforce GX220 and GS220 Monochrome LCD MonitorsEizo Nanao Corporation · 2007
- 1 generation backK120407 2MP Monochrome LCD Monitor, Radiforce GX240Eizo Nanao Corporation · 2012
- This deviceK151238 JUSHA-M23C LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000293 | Barco MGD 221 2 Megapixel Diagnostic Display | Barco N.V. | 2000 | — |
| −5 | K012099 | Monochrome Perfectly Flat Panel Displays, ME Series | Totoku Electric Co., Ltd. | 2001 | — |
| −4 | K022109 | Eizo, Model FC-2091 | Eizo Nanao Corporation | 2002 | — |
| −3 | K041597 | Monochrome LCD Monitor, Model Radiforce G22 | Eizo Nanao Corporation | 2004 | — |
| −2 | K070131 | Radiforce GX220 and GS220 Monochrome LCD Monitors | Eizo Nanao Corporation | 2007 | — |
| −1 | K120407 | 2MP Monochrome LCD Monitor, Radiforce GX240 | Eizo Nanao Corporation | 2012 | — |
| 0 (this device) | K151238 | JUSHA-M23C LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | 2015 | — |
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 |
|---|---|---|---|
| * | K120407 | 2MP Monochrome LCD Monitor, Radiforce GX240Summary page 4…ome LCD Monitor Classification Name: Product System, image processing 21CFR 892.2050 Code: PGY Predicate Device(s): RADIFORCE GX240; K120407 Device Description: JUSHA-M23C LCD Monitor is the display system with the high resoluti… | 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 15 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K120407.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
JUSHA-M23C LCD Monitor is intended to be used in displaying and viewing digital images by trained medical practitioners. JUSHA-M23C LCD Monitor does not support the display of mammography images for diagnosis.
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/K151238 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151238: JUSHA-M23C LCD Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151238
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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