510(k) · Cleared
ClearedDiagnostic Imaging Color LCD Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nec Display Solutions, Ltd. · PGY Display, Diagnostic Radiology
Cleared on May 13, 2016 as substantially equivalent to K142951 (Nec Display Solutions, Ltd., 2014) after a 29-day review. Its family tree reaches back 9 generations to 2000.
- Decided
- May 13, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K000293 (2000). No later device cites it as a predicate yet.
- Root · 9 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
- 5 generations between
- 3 generations backK090215 MD213MG 21.3 Diagnostic Imaging LCD Monitor - L218TLNec Display Solutions, Ltd. · 2009
- 2 generations backK130770 MD211C3 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2013
- 1 generation backK142951 MD210C3 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2014
- This deviceK161057 Diagnostic Imaging Color LCD MonitorNec Display Solutions, Ltd. · 2016
Show all 9 generations
- Root · 9 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
- 8 generations backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
- 7 generations backK022109 Eizo, Model FC-2091Eizo Nanao Corporation · 2002
- 6 generations backK041597 Monochrome LCD Monitor, Model Radiforce G22Eizo Nanao Corporation · 2004
- 5 generations backK061303 Medical Display, Models MDM 1900-1NG and MDM 1900-1NRChi Lin Technology Co., Ltd. · 2006
- 4 generations backK063266 3MP Medical Monochrome Reference Display, Model MDM2130-3NCChi Lin Technology Co., Ltd. · 2006
- 3 generations backK090215 MD213MG 21.3 Diagnostic Imaging LCD Monitor - L218TLNec Display Solutions, Ltd. · 2009
- 2 generations backK130770 MD211C3 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2013
- 1 generation backK142951 MD210C3 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2014
- This deviceK161057 Diagnostic Imaging Color LCD MonitorNec Display Solutions, Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K000293 | Barco MGD 221 2 Megapixel Diagnostic Display | Barco N.V. | 2000 | — |
| −8 | K012099 | Monochrome Perfectly Flat Panel Displays, ME Series | Totoku Electric Co., Ltd. | 2001 | — |
| −7 | K022109 | Eizo, Model FC-2091 | Eizo Nanao Corporation | 2002 | — |
| −6 | K041597 | Monochrome LCD Monitor, Model Radiforce G22 | Eizo Nanao Corporation | 2004 | — |
| −5 | K061303 | Medical Display, Models MDM 1900-1NG and MDM 1900-1NR | Chi Lin Technology Co., Ltd. | 2006 | — |
| −4 | K063266 | 3MP Medical Monochrome Reference Display, Model MDM2130-3NC | Chi Lin Technology Co., Ltd. | 2006 | — |
| −3 | K090215 | MD213MG 21.3 Diagnostic Imaging LCD Monitor - L218TL | Nec Display Solutions, Ltd. | 2009 | — |
| −2 | K130770 | MD211C3 21.3 Diagnostic Imaging LCD Monitor | Nec Display Solutions, Ltd. | 2013 | — |
| −1 | K142951 | MD210C3 21.3 Diagnostic Imaging LCD Monitor | Nec Display Solutions, Ltd. | 2014 | — |
| 0 (this device) | K161057 | Diagnostic Imaging Color LCD Monitor | Nec Display Solutions, Ltd. | 2016 | — |
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 |
|---|---|---|---|
| * | K142951 | MD210C3 21.3 Diagnostic Imaging LCD MonitorSummary page 4…II 4. Identification of Predicate Device(s) The identified predicates within this submission are as follows: 510(k) Number K142951 Applicant NEC Display Solutions Ltd. Device Name MD210C3 21.3” Diagnostic Imaging LCD moni… | 2014 |
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 5 companies; a new generation was cleared every 1.6 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K142951.
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 MDC212C2 Color displays are intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.
To guarantee the display performance as specified, it must only be used in conjunction with NEC approved display controllers.
MDC212C2 cannot be used for a life-support system.
This device must not be used in digital mammography.
This device is designed for exclusive interconnection with IEC 60601-1-1 certified equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161057: Diagnostic Imaging Color LCD Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161057
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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