510(k) · Cleared
ClearedLCD Monitor (C1216W, C822W, C821W)
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 29, 2025 as substantially equivalent to K231026 (Shenzhen Beacon Display Technology Co., Ltd., 2023) and 2 other predicates after a 30-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Oct 29, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K000293 (2000). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
- 6 generations backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
- 5 generations backK022109 Eizo, Model FC-2091Eizo Nanao Corporation · 2002
- 4 generations backK041597 Monochrome LCD Monitor, Model Radiforce G22Eizo Nanao Corporation · 2004
- 3 generations backK070131 Radiforce GX220 and GS220 Monochrome LCD MonitorsEizo Nanao Corporation · 2007
- 2 generations backK120407 2MP Monochrome LCD Monitor, Radiforce GX240Eizo Nanao Corporation · 2012
- 1 generation backK172815 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)Shenzhen Beacon Display Technology Co., Ltd. · 2017
- This deviceK253242 LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000293 | Barco MGD 221 2 Megapixel Diagnostic Display | Barco N.V. | 2000 | — |
| −6 | K012099 | Monochrome Perfectly Flat Panel Displays, ME Series | Totoku Electric Co., Ltd. | 2001 | — |
| −5 | K022109 | Eizo, Model FC-2091 | Eizo Nanao Corporation | 2002 | — |
| −4 | K041597 | Monochrome LCD Monitor, Model Radiforce G22 | Eizo Nanao Corporation | 2004 | — |
| −3 | K070131 | Radiforce GX220 and GS220 Monochrome LCD Monitors | Eizo Nanao Corporation | 2007 | — |
| −2 | K120407 | 2MP Monochrome LCD Monitor, Radiforce GX240 | Eizo Nanao Corporation | 2012 | — |
| −1 | K172815 | 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) | Shenzhen Beacon Display Technology Co., Ltd. | 2017 | — |
| 0 (this device) | K253242 | LCD Monitor (C1216W, C822W, C821W) | Shenzhen Beacon Display Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 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? (3)
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 |
|---|---|---|---|
| * | K231026 | 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference…Summary page 5…entification of Predicate Device(s) The identified predicate devices within this submission are as follows. Predicate Device for C1216W 510(k) Number: K231026 Applicant: Shenzhen Beacon Display Technology Co., Ltd. Trade Name: C1216W Predicate Device for C822W… | 2023 |
| * | K172815 | 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)Summary page 5…k) Number: K231026 Applicant: Shenzhen Beacon Display Technology Co., Ltd. Trade Name: C1216W Predicate Device for C822W 510(k) Number: K172815 510(k) Summary 1 LCD Monitors… | 2017 |
| * | K200864 | 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+Summary page 6…510(k) Submission Applicant: Shenzhen Beacon Display Technology Co., Ltd. Trade Name: C22S+ Predicate Device for C821W 510(k) Number: K200864 Applicant: Shenzhen Beacon Display Technology Co., Ltd. Trade Name: C53S+ 4. Description of the Device C12… | 2020 |
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 25 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 20 ancestors has a recall.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
-- C822W This Medical Monitor is intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis. -- C1216W This Medical Monitor is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical…
Read the full statement (107 words)
-- C822W
This Medical Monitor is intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
-- C1216W
This Medical Monitor is 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.
-- C821W
This Medical Monitor is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It's 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/K253242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253242: LCD Monitor (C1216W, C822W, C821W).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253242
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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