510(k) · Cleared
Cleared5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Beacon Display Technology Co., Ltd. · PGY Display, Diagnostic Radiology
Cleared on Feb 6, 2024 as substantially equivalent to K191137 (Jvckenwood Corporation, 2019) after a 57-day review. Its family tree reaches back 4 generations to 2011.
- Decided
- Feb 6, 2024
- Review
- 57 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K103792 (2011). No later device cites it as a predicate yet.
- Root · 4 generations backK103792 Barco Mammo TomosynthesisBarco N.V. · 2011
- 3 generations backK151883 5MP Monochrome LCD Monitor, RadiForce GX540Eizo Corporation · 2015
- 2 generations backK160326 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2…Jvckenwood Corporation · 2016
- 1 generation backK191137 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500Jvckenwood Corporation · 2019
- This deviceK233897 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S…Shenzhen Beacon Display Technology Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K103792 | Barco Mammo Tomosynthesis | Barco N.V. | 2011 | — |
| −3 | K151883 | 5MP Monochrome LCD Monitor, RadiForce GX540 | Eizo Corporation | 2015 | — |
| −2 | K160326 | 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) | Jvckenwood Corporation | 2016 | — |
| −1 | K191137 | 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 | Jvckenwood Corporation | 2019 | — |
| 0 (this device) | K233897 | 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP… | Shenzhen Beacon Display Technology Co., Ltd. | 2024 | — |
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 |
|---|---|---|---|
| * | K191137 | 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500Summary page 7…this submission is as follows: JVC Kenwood Corporation, 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 has been cleared by FDA through 510(k) No. K191137 (Decision Date - July 2, 2019). 5. Description of the Device [21 CFR 807.92(a) (4)] 5MP LCD Monitors C510S, G510S, CB5MP,… | 2019 |
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 4 companies; a new generation was cleared every 4.4 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K191137.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
C510S, G510S, CB5MP, MB5MP, C516S and G516S are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. They’re intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233897 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233897: 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233897
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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