# K961403: Life Imaging Systems Lis 6000 a

- Pathway: 510(k) (Traditional)
- Applicant: Life Imaging Systems, Inc.
- Decided: Jul 3, 1996 after 83 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but 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.

## Most influential descendants
- K992303: Sonographic Planning of Oncology Treatments (Spot), Model V.. 1.0 (2000), 6 descendants of its own
- K022739: Real Time HDR (220V), Model 132.001; Real Time HDR (110V), Model 132.002 (2002), 4 descendants of its own
- K031158: Swift 2.0, Model 132.001 (2003), 3 descendants of its own
- K022741: Spot Pro (220V), Model 131.099 (2002), 2 descendants of its own
- K112420: Oncentra Prostate 4.0 (2011), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K961403
Methodology: https://510kreport.com/methodology