510(k) · Cleared
Cleared4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+
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 Oct 19, 2020 as substantially equivalent to K130070 (Eizo Nanao Corporation, 2013) after a 61-day review. Its family tree reaches back 1 generation to 2013. 1 later device descends from it.
- Decided
- Oct 19, 2020
- Review
- 61 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K130070 (2013). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK130070 4MP Color LCD Monitor, Radiforce RX440Eizo Nanao Corporation · 2013
- This deviceK202374 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+Shenzhen Beacon Display Technology Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK222208 Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30DQingdao Hisense Medical Equipment Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K222208Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30DQingdao Hisense Medical Equipment Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K130070 | 4MP Color LCD Monitor, Radiforce RX440 | Eizo Nanao Corporation | 2013 | — |
| 0 (this device) | K202374 | 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+ | Shenzhen Beacon Display Technology Co., Ltd. | 2020 | — |
| +1 | K222208 | Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D | Qingdao Hisense Medical Equipment Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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 |
|---|---|---|---|
| * | K130070 | 4MP Color LCD Monitor, Radiforce RX440Summary page 5…ao Corporation, RadiForce RX440 has been cleared by FDA through 510(k) No. 510(k) Summary 7-1 LCD Monitors C44W+, C82W+, C83W+, C85W+ 510(k) Submission K130070 (Decision Date - February 08, 2013). 5. Description of the Device [21 CFR 807.92(a) (4)] C44W+ is a 30-inch TFT color LCD monit… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222208 | Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D | 2022 | 0 |
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?
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?
These products are intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. They 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/K202374 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202374: 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202374
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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