510(k) · Cleared
ClearedJUSHA-M350G/JUSHA-M350/M350G/M350 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 Feb 4, 2019 as substantially equivalent to K141690 (Nanjing Jusha Display Technology Co., Ltd., 2014) and 1 other predicate after a 49-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- Feb 4, 2019
- Review
- 49 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K000293 (2000). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
- 7 generations backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
- 6 generations backK022109 Eizo, Model FC-2091Eizo Nanao Corporation · 2002
- 5 generations backK052337 Monochrome LCD Monitor, Model Radiforce G33Eizo Nanao Corporation · 2005
- 4 generations backK060845 Monochrome LCD Monitor, Radiforce Model GS310Eizo Nanao Corporation · 2006
- 3 generations backK062053 Monochrome LCD Monitor, Radiforce, GS320Eizo Nanao Corporation · 2006
- 2 generations backK113784 3MP Monochrome LCD Monitor, Radiforce GX340Eizo Nanao Corporation · 2012
- 1 generation backK141690 Jusha-M33C LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2014
- This deviceK183499 JUSHA-M350G/JUSHA-M350/M350G/M350 LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K000293 | Barco MGD 221 2 Megapixel Diagnostic Display | Barco N.V. | 2000 | — |
| −7 | K012099 | Monochrome Perfectly Flat Panel Displays, ME Series | Totoku Electric Co., Ltd. | 2001 | — |
| −6 | K022109 | Eizo, Model FC-2091 | Eizo Nanao Corporation | 2002 | — |
| −5 | K052337 | Monochrome LCD Monitor, Model Radiforce G33 | Eizo Nanao Corporation | 2005 | — |
| −4 | K060845 | Monochrome LCD Monitor, Radiforce Model GS310 | Eizo Nanao Corporation | 2006 | — |
| −3 | K062053 | Monochrome LCD Monitor, Radiforce, GS320 | Eizo Nanao Corporation | 2006 | — |
| −2 | K113784 | 3MP Monochrome LCD Monitor, Radiforce GX340 | Eizo Nanao Corporation | 2012 | — |
| −1 | K141690 | Jusha-M33C LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | 2014 | — |
| 0 (this device) | K183499 | JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | K141690 | Jusha-M33C LCD MonitorSummary page 4…rome LCD Monitor Classification Name: Display, Diagnostic Radiology 21CFR 892.2050 PGY Product Code: Predicate Device(s): JUSHA-M33C; K141690 Device Description: JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor is the display system with the… | 2014 |
| * | K141684 | Jusha-C33C LCD MonitorSummary page 7…Differences Product JUSHA-M33C JUSHA-M350G/JUSHA-M3 50/M350G/M350 510(k) Number K141684 / Display Performance/Specifications Screen 21.3" Color TFT LC… | 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 19 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 13 ancestors has a recall.
- 1 other device also cites its predicate K141690.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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-M350G/JUSHA-M350/M350G/M350 LCD Monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device 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/K183499 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183499: JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183499
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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