510(k) · Cleared
ClearedLCD monitor (HMD3C21S), LCD monitor (HMD5G21S)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qingdao Hisense Medical Equipment Co., Ltd. · PGY Display, Diagnostic Radiology
Cleared on Jul 26, 2022 as substantially equivalent to K201211 (Shenzhen Beacon Display Technology Co., Ltd., 2020) and 1 other predicate after a 56-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- Jul 26, 2022
- Review
- 56 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K000293 (2000). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
- 7 generations backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
- 6 generations backK022109 Eizo, Model FC-2091Eizo Nanao Corporation · 2002
- 5 generations backK052337 Monochrome LCD Monitor, Model Radiforce G33Eizo Nanao Corporation · 2005
- 4 generations backK060845 Monochrome LCD Monitor, Radiforce Model GS310Eizo Nanao Corporation · 2006
- 3 generations backK062053 Monochrome LCD Monitor, Radiforce, GS320Eizo Nanao Corporation · 2006
- 2 generations backK113784 3MP Monochrome LCD Monitor, Radiforce GX340Eizo Nanao Corporation · 2012
- 1 generation backK201211 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors…Shenzhen Beacon Display Technology Co., Ltd. · 2020
- This deviceK221567 LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)Qingdao Hisense Medical Equipment Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K000293 | Barco MGD 221 2 Megapixel Diagnostic Display | Barco N.V. | 2000 | — |
| −7 | K012099 | Monochrome Perfectly Flat Panel Displays, ME Series | Totoku Electric Co., Ltd. | 2001 | — |
| −6 | K022109 | Eizo, Model FC-2091 | Eizo Nanao Corporation | 2002 | — |
| −5 | K052337 | Monochrome LCD Monitor, Model Radiforce G33 | Eizo Nanao Corporation | 2005 | — |
| −4 | K060845 | Monochrome LCD Monitor, Radiforce Model GS310 | Eizo Nanao Corporation | 2006 | — |
| −3 | K062053 | Monochrome LCD Monitor, Radiforce, GS320 | Eizo Nanao Corporation | 2006 | — |
| −2 | K113784 | 3MP Monochrome LCD Monitor, Radiforce GX340 | Eizo Nanao Corporation | 2012 | — |
| −1 | K201211 | 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+ | Shenzhen Beacon Display Technology Co., Ltd. | 2020 | — |
| 0 (this device) | K221567 | LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) | Qingdao Hisense Medical Equipment Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K201211 | 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+Summary page 4…on No. 892.2050 3. Legally Marketed Predicate Device Trade Name 3MP Color LCD Monitors C32S+, C32SP+, 3MP Monochrome 510(k) Number K201211 Product Code PGY Manufacturer Shenzhen Beacon Display Technology Co., Ltd. Trade… | 2020 |
| * | K191137 | 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500Summary page 4…logy Co., Ltd. Trade Name 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 510(k) Number K191137 Product Code PGY Manufacturer JVC KENWOOD Corporation 4. Device Description… | 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 22 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 18 ancestors has a recall of any class.
- 2 other devices also cite its predicate K201211.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
HMD3C21S :
The 3MP Color LCD Monitor HMD3C21S is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
HMD5G21S :
The 5MP Monochrome LCD Monitor HMD5G21S is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is 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/K221567 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221567: LCD monitor (HMD3C21S), LCD monitor (HMD5G21S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221567
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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