510(k) · Cleared
Recalled · Class II · 2021Nio Color 3MP (MDNC-3421)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Barco N.V. · PGY Display, Diagnostic Radiology
Cleared on Apr 5, 2017 as substantially equivalent to K131295 (Barco N.V., 2013) after a 15-day review. Its family tree reaches back 1 generation to 2013. 4 later devices descend from it. It has been recalled once.
- Decided
- Apr 5, 2017
- Review
- 15 days
- Class
- Class II
- Product code
- PGY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K131295 (2013). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK131295 Nio Color 3MP LedBarco N.V. · 2013
- This deviceK170837 Nio Color 3MP (MDNC-3421)Barco N.V. · 2017
- Descendant · cites it directly · 1 of its ownK230520 Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)Barco N.V. · 2023
- Descendant · 2 generations on · 0 of its ownK233693 Nio Color 8MP (MDNC-8132)Barco N.V. · 2023
- Descendant · cites it directly · 0 of its ownK191705 OptikView GUP2103CMIThe Linden Group Corp · 2020
- Descendant · cites it directly · 0 of its ownK171812 Nio Color 2MP (MDNC-2123)Barco N.V. · 2017
Most influential descendants
Showing 4 of 4 · See all- K230520Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)Barco N.V. · 2023 · cites it directly1descendant
- K233693Nio Color 8MP (MDNC-8132)Barco N.V. · 2023 · 2 generations on0descendants
- K191705OptikView GUP2103CMIThe Linden Group Corp · 2020 · cites it directly0descendants
- K171812Nio Color 2MP (MDNC-2123)Barco N.V. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K131295 | Nio Color 3MP Led | Barco N.V. | 2013 | — |
| 0 (this device) | K170837 | Nio Color 3MP (MDNC-3421) | Barco N.V. | 2017 | — |
| +1 | K230520 | Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) | Barco N.V. | 2023 | — |
| +2 | K233693 | Nio Color 8MP (MDNC-8132) | Barco N.V. | 2023 | — |
| +1 | K191705 | OptikView GUP2103CMI | The Linden Group Corp | 2020 | — |
| +1 | K171812 | Nio Color 2MP (MDNC-2123) | Barco N.V. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 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? (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 |
|---|---|---|---|
| * | K131295 | Nio Color 3MP LedSummary page 4…Classification code: PGY Regulation number: 892.2050 5. Predicate Nio Color 3MP (MDNC-3321) cleared under 510(K) K131295 device The MDNC-3421 is a derivative of the MDNC-3321. The modifications are: 6. Device… | 2013 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 22, 2021 | Class II | Z-1172-2021 | Process change control | A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Nio Color 3MP LED Medical Flat Panel Display System is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The display may be used in dental applications.
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/K170837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170837: Nio Color 3MP (MDNC-3421).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170837
Report an extraction error
Are you the manufacturer?
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