510(k) · Cleared
ClearedJusha-M33C 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 Aug 1, 2014 as substantially equivalent to K113784 (Eizo Nanao Corporation, 2012) after a 39-day review. Its family tree reaches back 7 generations to 2000. 2 later devices descend from it.
- Decided
- Aug 1, 2014
- Review
- 39 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K000293 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
- 6 generations backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
- 5 generations backK022109 Eizo, Model FC-2091Eizo Nanao Corporation · 2002
- 4 generations backK052337 Monochrome LCD Monitor, Model Radiforce G33Eizo Nanao Corporation · 2005
- 3 generations backK060845 Monochrome LCD Monitor, Radiforce Model GS310Eizo Nanao Corporation · 2006
- 2 generations backK062053 Monochrome LCD Monitor, Radiforce, GS320Eizo Nanao Corporation · 2006
- 1 generation backK113784 3MP Monochrome LCD Monitor, Radiforce GX340Eizo Nanao Corporation · 2012
- This deviceK141690 Jusha-M33C LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK222132 Hisense LCD monitor HMD2G21S, HMD3G21SQingdao Hisense Medical Equipment Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK183499 JUSHA-M350G/JUSHA-M350/M350G/M350 LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000293 | Barco MGD 221 2 Megapixel Diagnostic Display | Barco N.V. | 2000 | — |
| −6 | K012099 | Monochrome Perfectly Flat Panel Displays, ME Series | Totoku Electric Co., Ltd. | 2001 | — |
| −5 | K022109 | Eizo, Model FC-2091 | Eizo Nanao Corporation | 2002 | — |
| −4 | K052337 | Monochrome LCD Monitor, Model Radiforce G33 | Eizo Nanao Corporation | 2005 | — |
| −3 | K060845 | Monochrome LCD Monitor, Radiforce Model GS310 | Eizo Nanao Corporation | 2006 | — |
| −2 | K062053 | Monochrome LCD Monitor, Radiforce, GS320 | Eizo Nanao Corporation | 2006 | — |
| −1 | K113784 | 3MP Monochrome LCD Monitor, Radiforce GX340 | Eizo Nanao Corporation | 2012 | — |
| 0 (this device) | K141690 | Jusha-M33C LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | 2014 | — |
| +1 | K222132 | Hisense LCD monitor HMD2G21S, HMD3G21S | Qingdao Hisense Medical Equipment Co., Ltd. | 2022 | — |
| +1 | K183499 | JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K113784 | 3MP Monochrome LCD Monitor, Radiforce GX340Summary page 4…rome LCD Monitor Classification Name: Product Display, Diagnostic Radiology 21CFR 892.2050 Code: PGY Predicate Device(s): EIZO GX340;K113784 Device Description: JUSHA-M33C LCD Monitor is the display system with the high resoluti… | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K222132 (Qingdao Hisense Medical Equipment Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K113784.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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-M33C LCD Monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MR, etc. by trained medical practitioners. The device is not specified for digital mammography system.
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/K141690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141690: Jusha-M33C 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/K141690
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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