510(k) · Cleared
ClearedHisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D
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 Nov 17, 2022 as substantially equivalent to K183498 (Nanjing Jusha Display Technology Co., Ltd., 2019) and 2 other predicates after a 115-day review. Its family tree reaches back 6 generations to 2004.
- Decided
- Nov 17, 2022
- Review
- 115 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K033466 (2004). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK033466 Color LCD Display, Model Radiforce R22Eizo Nanao Corporation · 2004
- 5 generations backK052344 Color LCD Monitor, Model Radioforce R31 & R31-CEizo Nanao Corporation · 2005
- 4 generations backK090045 Color LCD Monitor, Radiforce RX320Eizo Nanao Corporation · 2009
- 3 generations backK113562 3MP Color LCD Monitor, Radiforce RX340Eizo Nanao Corporation · 2012
- 2 generations backK134002 6MP Color LCD Monitor, Radiforce RX650Eizo Corporation · 2014 · Recalled
- 1 generation backK163335 6MP Color LCD Monitor, RadiForce RX660, RX660-AREizo Corporation · 2016
- This deviceK222208 Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30DQingdao Hisense Medical Equipment Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K033466 | Color LCD Display, Model Radiforce R22 | Eizo Nanao Corporation | 2004 | — |
| −5 | K052344 | Color LCD Monitor, Model Radioforce R31 & R31-C | Eizo Nanao Corporation | 2005 | — |
| −4 | K090045 | Color LCD Monitor, Radiforce RX320 | Eizo Nanao Corporation | 2009 | — |
| −3 | K113562 | 3MP Color LCD Monitor, Radiforce RX340 | Eizo Nanao Corporation | 2012 | — |
| −2 | K134002 | 6MP Color LCD Monitor, Radiforce RX650 | Eizo Corporation | 2014 | 1 |
| −1 | K163335 | 6MP Color LCD Monitor, RadiForce RX660, RX660-AR | Eizo Corporation | 2016 | — |
| 0 (this device) | K222208 | Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D | Qingdao Hisense Medical Equipment Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K183498 | JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD MonitorSummary page 4…Nanjing Jusha JUSHA-C Display 1 K183498 PGY 270G Technology… | 2019 |
| * | K202374 | 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+Summary page 4…shenzhen Beacon Display 2 C44W+ K202374 PGY Technology Co.,… | 2020 |
| * | K163335 | 6MP Color LCD Monitor, RadiForce RX660, RX660-ARSummary page 4…Ltd. RadiForc EIZO 3 K163335 PGY e RX660 Corporation 9-1… | 2016 |
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 18 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 1 other device also cites its predicate K183498.
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?
These products are intended to be used in displaying radiological images for review, analysis and diagnosis 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/K222208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222208: Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222208
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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