510(k) · Cleared
Cleared12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)
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 Aug 18, 2023 as substantially equivalent to K200485 (Eizo Corporation, 2020) after a 129-day review. Its family tree reaches back 5 generations to 2011. 1 later device descends from it.
- Decided
- Aug 18, 2023
- Review
- 129 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K103792 (2011). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK103792 Barco Mammo TomosynthesisBarco N.V. · 2011
- 4 generations backK151883 5MP Monochrome LCD Monitor, RadiForce GX540Eizo Corporation · 2015
- 3 generations backK162497 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AREizo Corporation · 2016
- 2 generations backK172738 RadiForce RX560, RX560-AREizo Corporation · 2017
- 1 generation backK200485 RadiForce RX1270, RadiForce RX1270-AREizo Corporation · 2020
- This deviceK231026 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank…Shenzhen Beacon Display Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK253242 LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K253242LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K103792 | Barco Mammo Tomosynthesis | Barco N.V. | 2011 | — |
| −4 | K151883 | 5MP Monochrome LCD Monitor, RadiForce GX540 | Eizo Corporation | 2015 | — |
| −3 | K162497 | 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR | Eizo Corporation | 2016 | — |
| −2 | K172738 | RadiForce RX560, RX560-AR | Eizo Corporation | 2017 | — |
| −1 | K200485 | RadiForce RX1270, RadiForce RX1270-AR | Eizo Corporation | 2020 | — |
| 0 (this device) | K231026 | 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the… | Shenzhen Beacon Display Technology Co., Ltd. | 2023 | — |
| +1 | K253242 | LCD Monitor (C1216W, C822W, C821W) | Shenzhen Beacon Display Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K200485 | RadiForce RX1270, RadiForce RX1270-ARSummary page 5…510(k) Submission EIZO Corporation, 12MP Color LCD Monitor, RadiForce RX1270, RX1270-AR has been cleared by FDA through 510(k) No. K200485 (Decision Date - March 23, 2020). 5. Description of the Device [21 CFR 807.92(a) (4)] The C1216W and C12*** are 12MP color L… | 2020 |
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 |
|---|---|---|---|
| K253242 | LCD Monitor (C1216W, C822W, C821W) | 2025 | 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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K253242 (Shenzhen Beacon Display Technology Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K200485.
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?
These products are indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231026: 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231026
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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