510(k) · Cleared
ClearedJUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G 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 9, 2023 as substantially equivalent to K222121 (Nanjing Jusha Display Technology Co., Ltd., 2022) after an 85-day review. Its family tree reaches back 8 generations to 2004.
- Decided
- Jun 9, 2023
- Review
- 85 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K033466 (2004). No later device cites it as a predicate yet.
- Root · 8 generations backK033466 Color LCD Display, Model Radiforce R22Eizo Nanao Corporation · 2004
- 7 generations backK052344 Color LCD Monitor, Model Radioforce R31 & R31-CEizo Nanao Corporation · 2005
- 6 generations backK090045 Color LCD Monitor, Radiforce RX320Eizo Nanao Corporation · 2009
- 5 generations backK113562 3MP Color LCD Monitor, Radiforce RX340Eizo Nanao Corporation · 2012
- 4 generations backK134002 6MP Color LCD Monitor, Radiforce RX650Eizo Corporation · 2014 · Recalled
- 3 generations backK141679 Jusha-C61 LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2014
- 2 generations backK183492 JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor…Nanjing Jusha Display Technology Co., Ltd. · 2019
- 1 generation backK222121 C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor…Nanjing Jusha Display Technology Co., Ltd. · 2022
- This deviceK230728 JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD…Nanjing Jusha Display Technology Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K033466 | Color LCD Display, Model Radiforce R22 | Eizo Nanao Corporation | 2004 | — |
| −7 | K052344 | Color LCD Monitor, Model Radioforce R31 & R31-C | Eizo Nanao Corporation | 2005 | — |
| −6 | K090045 | Color LCD Monitor, Radiforce RX320 | Eizo Nanao Corporation | 2009 | — |
| −5 | K113562 | 3MP Color LCD Monitor, Radiforce RX340 | Eizo Nanao Corporation | 2012 | — |
| −4 | K134002 | 6MP Color LCD Monitor, Radiforce RX650 | Eizo Corporation | 2014 | 1 |
| −3 | K141679 | Jusha-C61 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | 2014 | — |
| −2 | K183492 | JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD… | Nanjing Jusha Display Technology Co., Ltd. | 2019 | — |
| −1 | K222121 | C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD… | Nanjing Jusha Display Technology Co., Ltd. | 2022 | — |
| 0 (this device) | K230728 | JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | 2023 | — |
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 |
|---|---|---|---|
| * | K222121 | C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitorSummary page 4…or LCD Monitor Classification Name: Medical Image Management and Processing System 21CFR 892.2050 Product Code: PGY Predicate Device(s): C630G, K222121 Device Description: JUSHA-C660G/JUSHA-C660/C660G/C660 LCD Monitor is the display system with hi… | 2022 |
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 3 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
C660G/C810G LCD Monitor is intended to be used in displaying and viewing digital images 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 as stated in the FDA summary.
https://510kreport.com/device/K230728 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230728: JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230728
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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