510(k) · Cleared
ClearedMammo Tomosynthesis (MDMG-5221)
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 May 18, 2016 as substantially equivalent to K090603 (Barco N.V., 2009) after a 16-day review. Its family tree reaches back 1 generation to 2009. 4 later devices descend from it.
- Decided
- May 18, 2016
- Review
- 16 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K090603 (2009). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK090603 Barco 5MP Mammo, Model MDMG-5221Barco N.V. · 2009
- This deviceK161229 Mammo Tomosynthesis (MDMG-5221)Barco N.V. · 2016
- Descendant · cites it directly · 2 of its ownK190848 JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK231170 C350/C350G LCD Monitor; M550/M550G LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK230723 C510G/JUSHA-C510G/C510/JUSHA- C510 LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK212231 C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor…Nanjing Jusha Display Technology Co., Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K190848JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2019 · cites it directly2descendants
- K231170C350/C350G LCD Monitor; M550/M550G LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2023 · cites it directly0descendants
- K230723C510G/JUSHA-C510G/C510/JUSHA- C510 LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2023 · 2 generations on0descendants
- K212231C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K090603 | Barco 5MP Mammo, Model MDMG-5221 | Barco N.V. | 2009 | — |
| 0 (this device) | K161229 | Mammo Tomosynthesis (MDMG-5221) | Barco N.V. | 2016 | — |
| +1 | K190848 | JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | 2019 | — |
| +1 | K231170 | C350/C350G LCD Monitor; M550/M550G LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | 2023 | — |
| +2 | K230723 | C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | 2023 | — |
| +2 | K212231 | C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210… | Nanjing Jusha Display Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K090603 | Barco 5MP Mammo, Model MDMG-5221Summary page 4…ification code: LLZ Regulation number: 892.2050 5. Predicate Mammo Tomosynthesis 5MP (MDMG-5221) cleared under 510(K) K090603 device MDMG-5221, system name Barco Mammo Tomosynthesis, is an update of the 5MP 6. Device… | 2009 |
What descends from it? (4)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K190848 (Nanjing Jusha Display Technology Co., Ltd., 2019) has gone furthest, with 2 descendants of its own.
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 Barco Mammo Tomosynthesis (MDMG-5221) device is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners.
It is specially designed for breast tomosynthesis applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161229: Mammo Tomosynthesis (MDMG-5221).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161229
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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