510(k) · Cleared
ClearedC350/C350G LCD Monitor; M550/M550G 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 7, 2023 as substantially equivalent to K183498 (Nanjing Jusha Display Technology Co., Ltd., 2019) and 1 other predicate after a 43-day review. Its family tree reaches back 4 generations to 2010.
- Decided
- Jun 7, 2023
- Review
- 43 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K092613 (2010). 6 ancestors in all, the oldest K090603 (2009). No later device cites it as a predicate yet.
- Root · 4 generations backK092613 Color LCD Monitor, Model Radiforce RS210Eizo Nanao Corporation · 2010
- 3 generations backK113844 Radiforce RX240Eizo Nanao Corporation · 2012
- 2 generations backK151861 JUSHA-C23C LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2015
- 1 generation backK183498 JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2019
- This deviceK231170 C350/C350G LCD Monitor; M550/M550G LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K092613 | Color LCD Monitor, Model Radiforce RS210 | Eizo Nanao Corporation | 2010 | — |
| −3 | K113844 | Radiforce RX240 | Eizo Nanao Corporation | 2012 | — |
| −2 | K151861 | JUSHA-C23C LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | 2015 | — |
| −1 | K183498 | JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | 2019 | — |
| 0 (this device) | K231170 | C350/C350G LCD Monitor; M550/M550G LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K183498 | JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD MonitorSummary page 5…892.2050 Product Code: PGY Device Class: Class II Predicate Device(s): C270G;K183498 BARCO MDMG-5221; K161229 Classification Name: Medical Image Management and Processing System, 21 CFR… | 2019 |
| * | K161229 | Mammo Tomosynthesis (MDMG-5221)Summary page 5…PGY Device Class: Class II Predicate Device(s): C270G;K183498 BARCO MDMG-5221; K161229 Classification Name: Medical Image Management and Processing System, 21 CFR 892.2050 Product Code:… | 2016 |
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 13 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K183498.
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?
C350G/C350/JUSHA-C350G/JUSHA-C350 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 is not specified for digital mammography system. M550G/ M550 /JUSHA-M550G/JUSHA-M550 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained…
Read the full statement (97 words)
C350G/C350/JUSHA-C350G/JUSHA-C350 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 is not specified for digital mammography system.
M550G/ M550 /JUSHA-M550G/JUSHA-M550 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially de displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231170: C350/C350G LCD Monitor; M550/M550G 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/K231170
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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