510(k) · Cleared
ClearedPacsmate MMD-3213M Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iei Technology Corp. · LLZ System, Image Processing, Radiological
Cleared on Sep 9, 2008 as substantially equivalent to K062053 (Eizo Nanao Corporation, 2006) after an 11-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Sep 9, 2008
- Review
- 11 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K000293 (2000). No later device cites it as a predicate yet.
- Root · 6 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
- 5 generations backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
- 4 generations backK022109 Eizo, Model FC-2091Eizo Nanao Corporation · 2002
- 3 generations backK052337 Monochrome LCD Monitor, Model Radiforce G33Eizo Nanao Corporation · 2005
- 2 generations backK060845 Monochrome LCD Monitor, Radiforce Model GS310Eizo Nanao Corporation · 2006
- 1 generation backK062053 Monochrome LCD Monitor, Radiforce, GS320Eizo Nanao Corporation · 2006
- This deviceK082496 Pacsmate MMD-3213M MonitorIei Technology Corp. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000293 | Barco MGD 221 2 Megapixel Diagnostic Display | Barco N.V. | 2000 | — |
| −5 | K012099 | Monochrome Perfectly Flat Panel Displays, ME Series | Totoku Electric Co., Ltd. | 2001 | — |
| −4 | K022109 | Eizo, Model FC-2091 | Eizo Nanao Corporation | 2002 | — |
| −3 | K052337 | Monochrome LCD Monitor, Model Radiforce G33 | Eizo Nanao Corporation | 2005 | — |
| −2 | K060845 | Monochrome LCD Monitor, Radiforce Model GS310 | Eizo Nanao Corporation | 2006 | — |
| −1 | K062053 | Monochrome LCD Monitor, Radiforce, GS320 | Eizo Nanao Corporation | 2006 | — |
| 0 (this device) | K082496 | Pacsmate MMD-3213M Monitor | Iei Technology Corp. | 2008 | — |
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 |
|---|---|---|---|
| * | K062053 | Monochrome LCD Monitor, Radiforce, GS320Summary page 1…e Product Code: LLZ 8. Predicate Device: Manufacturer: EIZO NANAG CORPORATION Device name: Monochrome LCD monitor Model name: RadiForce GS320 5 10(k) No.: K0620 53 9. Device Description: The MMVD-32 13M LCD monitors are displays for medical image viewing. MMD-3213M provides 3 mega pixel… | 2006 |
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 8 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K062053.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 device is intended to be used to as a tool in displaying and viewing digital images view and analyses by trained medical practitioner. The device is not specified for digital mammography system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082496 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082496: Pacsmate MMD-3213M Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082496
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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