510(k) · Cleared
ClearedLife Imaging Systems Lis 6000 a
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Imaging Systems, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jul 3, 1996 after an 83-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 9 later devices descend from it.
- Decided
- Jul 3, 1996
- Review
- 83 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
9 later devices descend from it, 3 citing it directly.
- This deviceK961403 Life Imaging Systems Lis 6000 aLife Imaging Systems, Inc. · 1996
- Descendant · cites it directly · 6 of its ownK992303 Sonographic Planning of Oncology Treatments (Spot), Model V.. 1.0Nucletron Corp. · 2000
- Descendant · 2 generations on · 4 of its ownK022739 Real Time HDR (220V), Model 132.001; Real Time HDR (110V), Model…Nucletron Corporation · 2002
- Descendant · 3 generations on · 3 of its ownK031158 Swift 2.0, Model 132.001Nucletron Corp. · 2003
- Descendant · 2 generations on · 2 of its ownK022741 Spot Pro (220V), Model 131.099Nucletron Corporation · 2002
- Descendant · 3 generations on · 1 of its ownK112420 Oncentra Prostate 4.0Nucletron · 2011
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K992303Sonographic Planning of Oncology Treatments (Spot), Model V.. 1.0Nucletron Corp. · 2000 · cites it directly6descendants
- K022739Real Time HDR (220V), Model 132.001; Real Time HDR (110V), Model 132.002Nucletron Corporation · 2002 · 2 generations on4descendants
- K031158Swift 2.0, Model 132.001Nucletron Corp. · 2003 · 3 generations on3descendants
- K022741Spot Pro (220V), Model 131.099Nucletron Corporation · 2002 · 2 generations on2descendants
- K112420Oncentra Prostate 4.0Nucletron · 2011 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961403 | Life Imaging Systems Lis 6000 a | Life Imaging Systems, Inc. | 1996 | — |
| +1 | K992303 | Sonographic Planning of Oncology Treatments (Spot), Model V.. 1.0 | Nucletron Corp. | 2000 | — |
| +2 | K022739 | Real Time HDR (220V), Model 132.001; Real Time HDR (110V), Model 132.002 | Nucletron Corporation | 2002 | — |
| +3 | K031158 | Swift 2.0, Model 132.001 | Nucletron Corp. | 2003 | — |
| +2 | K022741 | Spot Pro (220V), Model 131.099 | Nucletron Corporation | 2002 | — |
| +3 | K112420 | Oncentra Prostate 4.0 | Nucletron | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K941332 | TomTec EchoScan Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…0A -~ Alignment Phantom Life Imaging Systems LIS 8150A — Endocavity Probe Alignment Jig 3D /4D Ultrasound Image Acquisition and Postprocessing System TomTec EchoScan, K941332. The LIS 6000 is a device which can acquire, display, and post process diagnostic ultrasound images. Acquisition Data acquisit… |
What descends from it? (9)
3 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?
- Of its descendants, K992303 (Nucletron Corp., 2000) has gone furthest, with 6 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 LIS 6000A is intended to acquire a full resolution set of B-Mode images. The source of these images is the analog video or digital video output of a diagnostic ultrasound system. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice). The LIS 6000A is intended to acquire a full resolution set of Color Flow images. The source of these images is the analog video or digital video outputs of a…
Read the full statement (297 words)
The LIS 6000A is intended to acquire a full resolution set of B-Mode images. The source of these images is the analog video or digital video output of a diagnostic ultrasound system. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice).
The LIS 6000A is intended to acquire a full resolution set of Color Flow images. The source of these images is the analog video or digital video outputs of a diagnostic ultrasound system. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice).
The LIS 6000A is intended to acquire a high resolution set of B-Mode loops. The source of these loops is the analog video or digital video output of a diagnostic ultrasound system. Gating is accomplished by analyzing externally generated cardiac and/or respiratory signals. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice).
The LIS 6000A is intended to acquire a high resolution set of Color Flow loops. The source of these loops is the analog video or digital video output of a diagnostic ultrasound system. Gating is accomplished by analyzing externally generated cardiac and/or respiratory signals. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice).
The LIS 6000 is intended to reformat the acquired B-Mode and Color Flow data sets into a single volumetric data space and subsequently display multiple planar cross sections of that space, either individually, or together in a 3D polyhedral display
The LIS 6000A is intended to display three different volumetric rendering display modes: Maximum intensity, surface rendering and volume rendering.
The LIS 6000A will make basic distance, area, and volume measurements based on boundaries defined in user selected cross sectional planes.
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/K961403 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961403: Life Imaging Systems Lis 6000 a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961403
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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