510(k) · Cleared
ClearedInsight Diagnostic Imaging Workstation
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 Dec 21, 1998 as substantially equivalent to K965179 (Neo Imagery Technologies, Inc., 1997) and 1 other predicate after a 154-day review. Its family tree reaches back 2 generations to 1995. 9 later devices descend from it.
- Decided
- Dec 21, 1998
- Review
- 154 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945188 (1995). 5 ancestors in all, the oldest K864854 (1987). 9 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
- 1 generation backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
- This deviceK982535 Insight Diagnostic Imaging WorkstationNeo Imagery Technologies, Inc. · 1998
- Descendant · cites it directly · 8 of its ownK990241 Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore…Accuimage Diagnostics Corp. · 1999
- Descendant · cites it directly · 1 of its ownK063221 Medweb Advanced 3D Web PacsNexsys Electronics, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK024149 PrimelungAccuimage Diagnostics Corp. · 2003
- Descendant · 2 generations on · 0 of its ownK082336 XR-ExpressNew Mexico Software, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK070868 LMS-Lung/TrackMedian Technologies · 2007
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K990241Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze, Accuscope…Accuimage Diagnostics Corp. · 1999 · cites it directly8descendants
- K063221Medweb Advanced 3D Web PacsNexsys Electronics, Inc. · 2006 · cites it directly1descendant
- K024149PrimelungAccuimage Diagnostics Corp. · 2003 · 2 generations on1descendant
- K082336XR-ExpressNew Mexico Software, Inc. · 2008 · 2 generations on0descendants
- K070868LMS-Lung/TrackMedian Technologies · 2007 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945188 | Cemax Vipstation and/or Software | Cemax, Inc. | 1995 | — |
| −1 | K961023 | Aidp (Accuimage Image Display Processor) | Accuimage, Inc. | 1996 | — |
| 0 (this device) | K982535 | Insight Diagnostic Imaging Workstation | Neo Imagery Technologies, Inc. | 1998 | — |
| +1 | K990241 | Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze… | Accuimage Diagnostics Corp. | 1999 | — |
| +1 | K063221 | Medweb Advanced 3D Web Pacs | Nexsys Electronics, Inc. | 2006 | — |
| +2 | K024149 | Primelung | Accuimage Diagnostics Corp. | 2003 | — |
| +2 | K082336 | XR-Express | New Mexico Software, Inc. | 2008 | — |
| +3 | K070868 | LMS-Lung/Track | Median Technologies | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K965179 | Insight Diagnostic Imaging Workstation Nit-DU0-ZooSummary page 1…em (PACS) Proprietary Name: Neo Imagery Technologies Inc., InSight™ Diagnostic Imaging Workstation . Substantial Equivalence InSight™, Diagnostic Imaging Workstation, K965179; Acculmage, AIDP (Acculmage Image Display Processor), K961023 6. Device Description and Intended Use The InSight™ Diagnostic Im… | 1997 |
| * | K961023 | Aidp (Accuimage Image Display Processor)Summary page 1…Sight™ Diagnostic Imaging Workstation . Substantial Equivalence InSight™, Diagnostic Imaging Workstation, K965179; Acculmage, AIDP (Acculmage Image Display Processor), K961023 6. Device Description and Intended Use The InSight™ Diagnostic Imaging Workstation receives image files from medical scanning d… | 1996 |
What descends from it? (9)
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 3 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K990241 (Accuimage Diagnostics Corp., 1999) has gone furthest, with 8 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 product is an image processing workstation software package designed to run on standard PC hardware. The hardware is all “off-the-shelf” standard computer components and may be purchased independently by the end user or supplied by NIT. The NIT InSight™ software receives image files from medical scanning devices, such as CT or MRI and performs real time viewing, image manipulation, 3D and 4D visualization, communication, and archiving.
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/K982535 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982535: Insight Diagnostic Imaging Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982535
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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