510(k) · Cleared
Cleared2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+
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 Jul 2, 2020 as substantially equivalent to K160247 (Eizo Corporation, 2016) and 1 other predicate after a 20-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Jul 2, 2020
- Review
- 20 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K000293 (2000). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
- 5 generations backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
- 4 generations backK022109 Eizo, Model FC-2091Eizo Nanao Corporation · 2002
- 3 generations backK041597 Monochrome LCD Monitor, Model Radiforce G22Eizo Nanao Corporation · 2004
- 2 generations backK070131 Radiforce GX220 and GS220 Monochrome LCD MonitorsEizo Nanao Corporation · 2007
- 1 generation backK120407 2MP Monochrome LCD Monitor, Radiforce GX240Eizo Nanao Corporation · 2012
- This deviceK201599 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+…Shenzhen Beacon Display Technology Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000293 | Barco MGD 221 2 Megapixel Diagnostic Display | Barco N.V. | 2000 | — |
| −5 | K012099 | Monochrome Perfectly Flat Panel Displays, ME Series | Totoku Electric Co., Ltd. | 2001 | — |
| −4 | K022109 | Eizo, Model FC-2091 | Eizo Nanao Corporation | 2002 | — |
| −3 | K041597 | Monochrome LCD Monitor, Model Radiforce G22 | Eizo Nanao Corporation | 2004 | — |
| −2 | K070131 | Radiforce GX220 and GS220 Monochrome LCD Monitors | Eizo Nanao Corporation | 2007 | — |
| −1 | K120407 | 2MP Monochrome LCD Monitor, Radiforce GX240 | Eizo Nanao Corporation | 2012 | — |
| 0 (this device) | K201599 | 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ | Shenzhen Beacon Display Technology Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K160247 | 2MP Color LCD Monitor, RadiForce RX250 and RX250-ARSummary page 8…ed predicates within this submission are as follows: EIZO Corporation, 2MP Color LCD Monitor, RadiForce RX250 and RX250-AR has been cleared by FDA through 510(k) No. K160247 (Decision Date - February 23, 2016). EIZO NANAO Corporation, 2MP Monochrome LCD Monitor, RadiForce GX240 has been cleared by… | 2016 |
| * | K120407 | 2MP Monochrome LCD Monitor, Radiforce GX240Summary page 8…0(k) No. K160247 (Decision Date - February 23, 2016). EIZO NANAO Corporation, 2MP Monochrome LCD Monitor, RadiForce GX240 has been cleared by FDA through 510(k) No. K120407 (Decision Date - April 19, 2012). 5. Description of the Device [21 CFR 807.92(a) (4)] C22S+, C22SP+/G22S+, G22SP+, G23S+, G2… | 2012 |
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 20 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 10 ancestors has a recall.
- 2 other devices also cite its predicate K160247.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ are intended to be used
in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. The monitors
do 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/K201599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201599: 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201599
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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