510(k) · Cleared
ClearedNio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)
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 Mar 21, 2023 as substantially equivalent to K133663 (Barco N.V., 2014) and 1 other predicate after a 22-day review. Its family tree reaches back 2 generations to 2013. 1 later device descends from it.
- Decided
- Mar 21, 2023
- Review
- 22 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K131295 (2013). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK131295 Nio Color 3MP LedBarco N.V. · 2013
- 1 generation backK170837 Nio Color 3MP (MDNC-3421)Barco N.V. · 2017 · Recalled
- This deviceK230520 Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)Barco N.V. · 2023
- Descendant · cites it directly · 0 of its ownK233693 Nio Color 8MP (MDNC-8132)Barco N.V. · 2023
Most influential descendants
Showing 1 of 1 · See all- K233693Nio Color 8MP (MDNC-8132)Barco N.V. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K131295 | Nio Color 3MP Led | Barco N.V. | 2013 | — |
| −1 | K170837 | Nio Color 3MP (MDNC-3421) | Barco N.V. | 2017 | 1 |
| 0 (this device) | K230520 | Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) | Barco N.V. | 2023 | — |
| +1 | K233693 | Nio Color 8MP (MDNC-8132) | Barco N.V. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K133663 | Nio Color 2MPSummary page 4…Regulation name: Medical Image Management and Processing System 5. Predicate MDNC-2521: Nio Color 2MP (MDNC-2221) cleared under 510(K) K133663 device Common name: MDNC-2221 Classification name… | 2014 |
| * | K170837 | Nio Color 3MP (MDNC-3421)Summary page 4…Regulation name: Medical Image Management and Processing System MDNC-3521: Nio Color 3MP (MDNC-3421) cleared under 510(k) K170837 Common name: MDNC-3421 Classification name:… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233693 | Nio Color 8MP (MDNC-8132) | 2023 | 0 |
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 10 years and passes through 1 company; a new generation was cleared every 6.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K233693 (Barco N.V., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K133663.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The display 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 as stated in the FDA summary.
https://510kreport.com/device/K230520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230520: Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230520
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