510(k) · Cleared
ClearedHisense LDC monitor models HMD2G21/HMD3G21/HMD5G21
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 Mar 3, 2016 as substantially equivalent to K091172 (Barco N.V., 2009) and 2 other predicates after a 24-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Mar 3, 2016
- Review
- 24 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K001753 (2000). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK001753 Medis 5MP2 Dual-Head Medical Diagnostic Display SystemBarco NV Display Systems · 2000
- 6 generations backK013922 Coronis 3MP Medicl Flat Panel Display SystemBarco N.V. · 2002
- 5 generations backK023341 Cornis 5MP Medical Flat Panel Display SystemBarco N.V. · 2002
- 4 generations backK032202 Dome CX Digital Flat-Panel Display System, Models C2 and C5IPlanar Systems, Inc. · 2003
- 3 generations backK040443 Dome CX Digital Flat-Panel Display System, Model C5IDome Imaging Systems, Inc. · 2004
- 2 generations backK042221 Coronis 5MP Medical Flat Panel Display SystemBarco NV Barcoview · 2004
- 1 generation backK062131 Nio 5MP-M-21 (Nio 5MP Mammo); MDNG-5121 BBBarcoview · 2006
- This deviceK160347 Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21Qingdao Hisense Medical Equipment Co., Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001753 | Medis 5MP2 Dual-Head Medical Diagnostic Display System | Barco NV Display Systems | 2000 | — |
| −6 | K013922 | Coronis 3MP Medicl Flat Panel Display System | Barco N.V. | 2002 | — |
| −5 | K023341 | Cornis 5MP Medical Flat Panel Display System | Barco N.V. | 2002 | — |
| −4 | K032202 | Dome CX Digital Flat-Panel Display System, Models C2 and C5I | Planar Systems, Inc. | 2003 | — |
| −3 | K040443 | Dome CX Digital Flat-Panel Display System, Model C5I | Dome Imaging Systems, Inc. | 2004 | — |
| −2 | K042221 | Coronis 5MP Medical Flat Panel Display System | Barco NV Barcoview | 2004 | — |
| −1 | K062131 | Nio 5MP-M-21 (Nio 5MP Mammo); MDNG-5121 BB | Barcoview | 2006 | — |
| 0 (this device) | K160347 | Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 | Qingdao Hisense Medical Equipment Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K091172 | Nio 2MP (MDNG-2121)Summary page 4…807.92(a) (3)] The identified predicates within this submission are as follows: BARCO N.V., Nio 2MP(MDNG-2121) has been cleared by FDA through 510(k) No. K091172, BARCO N.V., Nio 3MP(MDCG-3221) has been cleared by FDA through 510(k) No . K131246 BARCO N.V., Nio… | 2009 |
| * | K131246 | Coronis 3MPSummary page 4…, Nio 2MP(MDNG-2121) has been cleared by FDA through 510(k) No. K091172, BARCO N.V., Nio 3MP(MDCG-3221) has been cleared by FDA through 510(k) No . K131246 BARCO N.V., Nio 5MP(MDNG-5121) has been cleared by FDA through 510(k) No . K062131 510(k) Cover Letter… | 2013 |
| * | K062131 | Nio 5MP-M-21 (Nio 5MP Mammo); MDNG-5121 BBSummary page 4…Nio 3MP(MDCG-3221) has been cleared by FDA through 510(k) No . K131246 BARCO N.V., Nio 5MP(MDNG-5121) has been cleared by FDA through 510(k) No . K062131 510(k) Cover Letter 7-1 510(k) Submission… | 2006 |
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 16 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- None of the 10 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. 2016, 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?
The 2MP/3MP LCD Monitor (HMD2G21/HMD3G21) is intended to be used in displaying and viewing digital images
(excluding digital mammography) for review and analysis by trained medical practitioners.
The 5MP LCD Monitor (HMD5G21) is intended to be used in displaying and viewing digital images for review and
analysis by trained medical practitioners, including digital mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160347 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160347: Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160347
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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