510(k) · Cleared
ClearedNio 5MP-M-21 (Nio 5MP Mammo); MDNG-5121 BB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Barcoview · LLZ System, Image Processing, Radiological
Cleared on Nov 17, 2006 as substantially equivalent to K042221 (Barco NV Barcoview, 2004) after a 114-day review. Its family tree reaches back 6 generations to 2000. 2 later devices descend from it.
- Decided
- Nov 17, 2006
- Review
- 114 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001753 (2000). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK001753 Medis 5MP2 Dual-Head Medical Diagnostic Display SystemBarco NV Display Systems · 2000
- 5 generations backK013922 Coronis 3MP Medicl Flat Panel Display SystemBarco N.V. · 2002
- 4 generations backK023341 Cornis 5MP Medical Flat Panel Display SystemBarco N.V. · 2002
- 3 generations backK032202 Dome CX Digital Flat-Panel Display System, Models C2 and C5IPlanar Systems, Inc. · 2003
- 2 generations backK040443 Dome CX Digital Flat-Panel Display System, Model C5IDome Imaging Systems, Inc. · 2004
- 1 generation backK042221 Coronis 5MP Medical Flat Panel Display SystemBarco NV Barcoview · 2004
- This deviceK062131 Nio 5MP-M-21 (Nio 5MP Mammo); MDNG-5121 BBBarcoview · 2006
- Descendant · cites it directly · 0 of its ownK160347 Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21Qingdao Hisense Medical Equipment Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK081357 5MP Grayscale Flat Panel Display, Model, 6GF6201-5C$2# (Where $ =…Eizo GmbH · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001753 | Medis 5MP2 Dual-Head Medical Diagnostic Display System | Barco NV Display Systems | 2000 | — |
| −5 | K013922 | Coronis 3MP Medicl Flat Panel Display System | Barco N.V. | 2002 | — |
| −4 | K023341 | Cornis 5MP Medical Flat Panel Display System | Barco N.V. | 2002 | — |
| −3 | K032202 | Dome CX Digital Flat-Panel Display System, Models C2 and C5I | Planar Systems, Inc. | 2003 | — |
| −2 | K040443 | Dome CX Digital Flat-Panel Display System, Model C5I | Dome Imaging Systems, Inc. | 2004 | — |
| −1 | K042221 | Coronis 5MP Medical Flat Panel Display System | Barco NV Barcoview | 2004 | — |
| 0 (this device) | K062131 | Nio 5MP-M-21 (Nio 5MP Mammo); MDNG-5121 BB | Barcoview | 2006 | — |
| +1 | K160347 | Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 | Qingdao Hisense Medical Equipment Co., Ltd. | 2016 | — |
| +1 | K081357 | 5MP Grayscale Flat Panel Display, Model, 6GF6201-5C$2# (Where $ = a-Z and # =… | Eizo GmbH | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2016 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K042221 | Coronis 5MP Medical Flat Panel Display SystemSummary page 1…cation name: System, Image Processing * Classification number: 21 CFR 892.2050 / Procode 9OLLZ 5. Predicate device • Name: Coronis SMiP * 510(k) number: K042221 * Manufacturer: Barco NV 6. Device description Nio 5MP-M-21" is a display system for medical viewing. It consists of 3 com… | 2004 |
What descends from it? (2)
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?
- The line of descent spans 6 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K160347 (Qingdao Hisense Medical Equipment Co., Ltd., 2016) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K042221.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The MDNG-5121 BB is intended to be used in displaying and viewing digital images, including
digital mammography, for review and analasys by trained medical practitioners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062131: Nio 5MP-M-21 (Nio 5MP Mammo); MDNG-5121 BB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062131
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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