510(k) · Cleared
ClearedInsight Diagnostic Imaging Workstation Nit-DU0-Zoo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neo Imagery Technologies, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jul 3, 1997 as substantially equivalent to K893689 (Siemens Medical Solutions USA, Inc., 1989) and 1 other predicate after a 191-day review. Its family tree reaches back 1 generation to 1987. 10 later devices descend from it.
- Decided
- Jul 3, 1997
- Review
- 191 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K864854 (1987). 2 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK864854 View (TM) Image Processing and Viewing StationVirtual Imaging · 1987
- This deviceK965179 Insight Diagnostic Imaging Workstation Nit-DU0-ZooNeo Imagery Technologies, Inc. · 1997
- Descendant · cites it directly · 9 of its ownK982535 Insight Diagnostic Imaging WorkstationNeo Imagery Technologies, Inc. · 1998
- Descendant · 2 generations on · 8 of its ownK990241 Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore…Accuimage Diagnostics Corp. · 1999
- Descendant · 2 generations on · 1 of its ownK063221 Medweb Advanced 3D Web PacsNexsys Electronics, Inc. · 2006
- Descendant · 3 generations on · 1 of its ownK024149 PrimelungAccuimage Diagnostics Corp. · 2003
- Descendant · 3 generations on · 0 of its ownK082336 XR-ExpressNew Mexico Software, Inc. · 2008
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K982535Insight Diagnostic Imaging WorkstationNeo Imagery Technologies, Inc. · 1998 · cites it directly9descendants
- K990241Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze, Accuscope…Accuimage Diagnostics Corp. · 1999 · 2 generations on8descendants
- K063221Medweb Advanced 3D Web PacsNexsys Electronics, Inc. · 2006 · 2 generations on1descendant
- K024149PrimelungAccuimage Diagnostics Corp. · 2003 · 3 generations on1descendant
- K082336XR-ExpressNew Mexico Software, Inc. · 2008 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864854 | View (TM) Image Processing and Viewing Station | Virtual Imaging | 1987 | — |
| 0 (this device) | K965179 | Insight Diagnostic Imaging Workstation Nit-DU0-Zoo | Neo Imagery Technologies, Inc. | 1997 | — |
| +1 | K982535 | Insight Diagnostic Imaging Workstation | Neo Imagery Technologies, Inc. | 1998 | — |
| +2 | K990241 | Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze… | Accuimage Diagnostics Corp. | 1999 | — |
| +2 | K063221 | Medweb Advanced 3D Web Pacs | Nexsys Electronics, Inc. | 2006 | — |
| +3 | K024149 | Primelung | Accuimage Diagnostics Corp. | 2003 | — |
| +3 | K082336 | XR-Express | New Mexico Software, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K893689 | Vision Integrated Performance OptionSummary page 1…ge Processing Workstation Classification Name: RA 90 LLZ, Image Processing System, Class II 21 CFR § 892. classification unknown 3. Predicate Devices: Siemens V.I.P. ™ K893689 Virtual Imaging VIEW™ K864854/A 4. Device Description: The InSight™ Diagnostic Imaging Workstation provides real-time 3-D visu… | 1989 |
| * | K864854 | View (TM) Image Processing and Viewing StationSummary page 1…ification Name: RA 90 LLZ, Image Processing System, Class II 21 CFR § 892. classification unknown 3. Predicate Devices: Siemens V.I.P. ™ K893689 Virtual Imaging VIEW™ K864854/A 4. Device Description: The InSight™ Diagnostic Imaging Workstation provides real-time 3-D visualization, communication, archi… | 1987 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982535 | Insight Diagnostic Imaging Workstation | 1998 | 9 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K982535 (Neo Imagery Technologies, Inc., 1998) has gone furthest, with 9 descendants of its own.
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 InSight™ Diagnostic Imaging Workstation must be used by or on the order of a physician. The system receives digital information from scanning devices and mémipulates image data for the purpose of image characterization, enhancement, communication, archiving, and real-time 3D visualization. The system is designed as an aide to trained medical practitioners in the diagnostic process. Only qualified personnel should service system hardware and software.
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/K965179 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965179: Insight Diagnostic Imaging Workstation Nit-DU0-Zoo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965179
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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