(83 days)
Not Found
No
The description focuses on image acquisition, reformatting, display, and basic measurements, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is described as acquiring, displaying, and post-processing diagnostic ultrasound images, and its intended use focuses on image acquisition and display, which are diagnostic functions, not therapeutic ones.
No
The LIS 6000A acquires, displays, and processes images from an existing diagnostic ultrasound system. It does not generate the initial diagnostic images itself or perform the diagnostic interpretation. It is an image processing and display tool for pre-existing diagnostic images.
No
The device description explicitly mentions "probe positioning devices" which are hardware components, indicating it is not solely software.
Based on the provided information, the LIS 6000A is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- LIS 6000A Function: The LIS 6000A acquires, displays, and post-processes diagnostic ultrasound images. Ultrasound is an in vivo imaging modality, meaning it examines the body directly without taking specimens.
- Intended Use: The intended use clearly states the device acquires images from a "diagnostic ultrasound system" and performs tasks like reformatting, displaying, and making measurements on these images. This is consistent with an imaging post-processing device, not an IVD.
Therefore, the LIS 6000A falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / 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 excernally generator 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.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
LIS6000A
The LIS 6000 is a device which can acquire, display, and post process diagnostic ultrasound images.
Acquisition
Data acquisition involves video grabbing a set (or sets) of ultrasound frames, each frame representing a planar image, while positioning the ultrasound probe such that the set of 2D planes acquired spans a predefined volume with a known relationship between the planes. The probe positioning devices are described below. Three types of acquisitions are defined for the LIS 6000A: ungated, single phase gated and multiphase gated.
Ungated Acquisitions
In this type of acquisition the probe positioner moves at a pre-determined, constant rate set by the system as appropriate for the imaging conditions.
Single Phase Gated Acquisitions
In this type of acquisition at each pre-determined 2D slice position the gating criteria must be satisfied for a video frame to be acquired. Once a frame has been acquired the positioner can move to the next acquisition position.
Multi Phase Gated Acquisitions
In multi-phase gating acquisitions the gating criteria must be satisfied, and video acquisition accomplished, for all required phases at each slice position, before the positioner moves the probe to the next position. The resulting "3D Loop" data set compises an independent 3D data set at each phase of the acquisition. As with any motion picture, cartoon or the like, when like images from each phase are displayed in rapid succession a moving effect is created for the viewer.
Calibration
Calibration of the pixel dimensions is provided either through operator input immediately after an acquisition sequence has been completed, or through direct communication between the LIS 6000 and the ultrasound imaging system.
Alignment
Probe to probe variations of true image position are determined via a semiautomated alignment procedure utilizing the LIS Alignment Phantom and Alignment Jig, described below.
Post-Processing
Post processing involves two distinct steps. In the first step the set of planar images obtained in acquisition are re-aligned, based on the parameters obtained in the alignment procedure. In the second step the aligned images are reconstructed into a volume of data. These two steps may be carried out simultaneously from the operator's perspective.
Visualization/Image Manipulation
In the visualization step the operator can interactively view the post processed data using the following display types: faceted sub-volumes (convex polyhedra) , 2D planar slices, and rendered images.
Planar Measurements
Planar measurements may be made based on the pixel calibration and acquisition parameters. Measurements offered include distance, area, curve length and volume. Volumes are calculated based on planar areas multiplied by slice thickness. No geometric assumptions are made or computation models used.
LIS 8030A Linear Probe Positioner
The linear positioner is an electromechanical device intended to translate a standard ultrasound probe in as straight line across a patient's body. In operation the probe is mounted in a probe cradle which has been designed to accept a specific probe or probe family. The probe cradle is in turn mounted to a probe stage which is on the linear positioner. The probe stage is attached to and driven by a lead screw which in turn is driven by a DC motor/position encoder assembly. The position encoder allows the LIS 6000A software to track the absolute position of the probe. An optional stabilizer assembly mounts on the linear positioner to assist the operator in maintaining a steady contact with the patient. The linear positioner does not attempt to follow a curved body surface. In order to acquire images from body parts which have significantly curved surfaces, multiple shorter acquisitions may need to be utilized. Some degree of flexibility is afforded by having the probe slide across a small pool of acoustic couplant.
LIS 8000A Endocavity Probe Positioner
The axial positioner is an electromechanical device which is intended to rotate a standard ultrasound endocavity probe about its long axis while it is positioned in its normal imaging position within a patient's body. In operation the probe is mounted in a probe cradle which has been designed to accept a specific probe or probe family. The probe cradle is in turn mounted to a probe stage which is on the axial positioner. A position encoder allows the LIS 6000A software to track the absolute position of the probe. When end-fired endocavitary probes are being rotated the Endocavity positioner an axial data set is obtained. When side fired probes are rotated with the Endocavity positioner a sector data set is obtained.
LIS 8010A Alignment Phantom
The Alignment Phantom is an accessory device intended to be used with the Endocavity Positioner. Its function is to allow the critical alignment parameters, to be determined.
LIS 8050 Endocavity Alignhment Jig
The Endocavitary Probe Alignment Jig is a mechanical device which is an accessory to the Endocavitary Positioner. It is used to make certain that the center of the tip of an endocavitary probe is aligned with its axis of rotation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
TomTec EchoScan, K941332.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
| 510(k) Notification | |
|---|---|
| -- | --------------------- |
K961403
| Submitter's Name: | Life Imaging Systems |
|---|---|
| Submitter's Address: | 306A Weathervane Office Commons |
| Richboro, PA 18954 | |
| JUL - 3 1996 | |
| Voice Phone: | 215 364-6927 |
| Fax Phone: | 215 364-6928 |
| Contact: | Richard Derman |
| Device Name: | Life Imaging Systems LIS 6000A - Image Processing System |
| Life Imaging Systems LIS 8000A – Endocavity Probe Positioner | |
| Life Imaging Systems LIS 8030A - Linear Probe Positioner | |
| Life Imaging Systems LIS 8100A - Alignment Phantom | |
| Life Imaging Systems LIS 8150A – Endocavity Probe Alignment Jig | |
| Common Name: | 3D/4D Ultrasound Image Acquisition and Postprocessing System |
| Predicate Device: | TomTec EchoScan, K941332. |
Device Description:
LIS6000A
The LIS 6000 is a device which can acquire, display, and post process diagnostic ultrasound images.
Acquisition
Data acquisition involves video grabbing a set (or sets) of ultrasound frames, each frame representing a planar image, while positioning the ultrasound probe such that the set of 2D planes acquired spans a predefined volume with a known relationship between the planes. The probe positioning devices are described below. Three types of acquisitions are defined for the LIS 6000A: ungated, single phase gated and multiphase gated.
Ungated Acquisitions
In this type of acquisition the probe positioner moves at a pre-determined, constant rate set by the system as appropriate for the imaging conditions.
Single Phase Gated Acquisitions
In this type of acquisition at each pre-determined 2D slice position the gating criteria must be satisfied for a video frame to be acquired. Once a frame has been acquired the positioner can move to the next acquisition position.
Multi Phase Gated Acquisitions
In multi-phase gating acquisitions the gating criteria must be satisfied, and video acquisition accomplished, for all required phases at each slice position, before the positioner moves the probe to the next position. The resulting "3D Loop" data set compises an independent 3D data set at each phase of the acquisition. As with any motion picture, cartoon or the like, when like
1
images from each phase are displayed in rapid succession a moving effect is created for the viewer.
Calibration
Calibration of the pixel dimensions is provided either through operator input immediately after an acquisition sequence has been completed, or through direct communication between the LIS 6000 and the ultrasound imaging system.
Alignment
Probe to probe variations of true image position are determined via a semiautomated alignment procedure utilizing the LIS Alignment Phantom and Alignment Jig, described below.
Post-Processing
Post processing involves two distinct steps. In the first step the set of planar images obtained in acquisition are re-aligned, based on the parameters obtained in the alignment procedure. In the second step the aligned images are reconstructed into a volume of data. These two steps may be carried out simultaneously from the operator's perspective.
Visualization/Image Manipulation
In the visualization step the operator can interactively view the post processed data using the following display types: faceted sub-volumes (convex polyhedra) , 2D planar slices, and rendered images.
Planar Measurements
Planar measurements may be made based on the pixel calibration and acquisition parameters. Measurements offered include distance, area, curve length and volume. Volumes are calculated based on planar areas multiplied by slice thickness. No geometric assumptions are made or computation models used.
LIS 8030A Linear Probe Positioner
The linear positioner is an electromechanical device intended to translate a standard ultrasound probe in as straight line across a patient's body. In operation the probe is mounted in a probe cradle which has been designed to accept a specific probe or probe family. The probe cradle is in turn mounted to a probe stage which is on the linear positioner. The probe stage is attached to and driven by a lead screw which in turn is driven by a DC motor/position encoder assembly. The position encoder allows the LIS 6000A software to track the absolute position of the probe. An optional stabilizer assembly mounts on the linear positioner to assist the operator in maintaining a steady contact with the patient. The linear positioner does not attempt to follow a curved body surface. In order to acquire images from body parts which have significantly curved surfaces, multiple shorter acquisitions may need to be utilized. Some degree
2
of flexibility is afforded by having the probe slide across a small pool of acoustic couplant.
LIS 8000A Endocavity Probe Positioner
The axial positioner is an electromechanical device which is intended to rotate a standard ultrasound endocavity probe about its long axis while it is positioned in its normal imaging position within a patient's body. In operation the probe is mounted in a probe cradle which has been designed to accept a specific probe or probe family. The probe cradle is in turn mounted to a probe stage which is on the axial positioner. A position encoder allows the LIS 6000A software to track the absolute position of the probe. When end-fired endocavitary probes are being rotated the Endocavity positioner an axial data set is obtained. When side fired probes are rotated with the Endocavity positioner a sector data set is obtained.
LIS 8010A Alignment Phantom
The Alignment Phantom is an accessory device intended to be used with the Endocavity Positioner. Its function is to allow the critical alignment parameters, to be determined.
LIS 8050 Endocavity Alignhment Jig
The Endocavitary Probe Alignment Jig is a mechanical device which is an accessory to the Endocavitary Positioner. It is used to make certain that the center of the tip of an endocavitary probe is aligned with its axis of rotation.
Intended uses of the LIS 6000A
B-Mode Acquisition, Ungated or Single Phase Gated
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).
Color Flow Acquisition, Ungated or Single Phase Gated
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).
B-Mode Acquisition, Multi-Phase Gated
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).
Color Flow Acquisition, Multi-Phase Gated
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
3
externally generated cardiac and/or respiratory signals. Image acquisition excernally generator linear (parallel slice), axial (propeller slice) or sector (fan slice).
Image Display and Postprocessing
Reformatting and Basic Display
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
Volumetric Rendering
The LIS 6000A is intended to display three different volumetric rendering display modes: Maximum intensity, surface rendering and volume rendering.
Measurements
The LIS 6000A will make basic distance, area, and volume measurements based on boundaries defined in user selected cross sectional planes.
4
Comparison of the LIS 6000A and the TomTec EchoScan
of the LIS 6000A and the Touries Lehoccan
The following table compares the relevant features of the TomTec EchoScan
and the LIS 6000A
| Property/Feature | LIS 6000A | TomTec EchoScan |
|---|---|---|
| Device Use | Adjunct to ultrasound system | Adjunct to ultrasound system |
| Data Source | 2D images from standard ultrasound system | 2D images from standard ultrasound system |
| Scan Plane Positioning | Motor driven, ultrasound probe adapter | Motor driven, ultrasound probe adapter |
| Acquisition Gating types | None, Respiration, ECG, ECG and Respiration | None, Respiration, ECG, ECG and Respiration |
| Patient Contact Electrodes | No - Requires external ECG trigger and Respiration signals | Yes - On board ECG/Impedance plethysmograph |
| Effect on US acoustic output | None | None |
| Reconstructed 2D Slices | Yes | Yes |
| Rendering Modes | Surface, Volume, Maximum Intensity Projection | Surface, Maximum Intensity Projection, Minimum Intensity |
| Video Acquisition | Grayscale, Color | Grayscale |
| Measurements | Distance, Area, Volume | Distance, Area, Volume, 3D Distance |
| Artifact Reduction Processing | Probe mis-alignment and respiration | Respiration |
| Compression | None Lossless | None |