(60 days)
Not Found
No
The description focuses on image storage, display, and network access, with no mention of AI/ML algorithms for analysis or interpretation.
No.
The device is described as software for storing and displaying digital images from ultrasound systems, and provides tools for review and diagnosis, but does not provide any therapy.
No
The device description states that the EchoNet Client "permits review and diagnosis of ultrasound imagery and demographics." However, the "Intended Use / Indications for Use" section focuses on storing and displaying digital images and data, and nowhere does it state that the device is intended to provide a medical diagnosis on its own. It's a tool for review and storage, supporting diagnosis but not performing it.
No
The device description explicitly states that EchoNet is composed of "Unix workstation which permits review and diagnosis" and "Unix workstation based database and image server software combined with a virtual file system." While the core functionality is software, it is described as running on and including specific hardware components (Unix workstations and mass storage devices). Therefore, it is not a software-only medical device.
Based on the provided information, EchoNet is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use of EchoNet is for storing and displaying digital images acquired by digital ultrasound imaging systems. It provides access to imagery and patient demographic data.
- Device Description: The device description reinforces this by detailing the software's functions for reviewing and diagnosing ultrasound imagery, including display controls and storage capabilities.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. EchoNet does not interact with or analyze biological specimens. It handles and displays medical images.
Therefore, EchoNet falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
EchoNet is software which runs on Unix workstations. EchoNet is intended to be used for storing and displaying digital imaqes acquired by digital ultrasound imaging systems. EchoNet provides rapid network access to the imagery and patient demographic data stored on a central server. The system retrieves and stores images as unaltered computer data and as JPEG (Joint Photographic Experts Group) lossy compressed cine-loops. This dual-path storage system allows for rapid access to high quality compressed images with the original unaltered (losslessly compressed) images available on demand. EchoNet is a scalable network system designed to service customers ranging in size from small departments (with 2 or 3 users) to large hospital networks (with tens of users).
Product codes
Device, Digital Image Storage
Device Description
EchoNet is composed of the following:
Unix workstation which permits review and diagnosis of EchoNet Client: ultrasound imagery and demographics. This review software provides basic controls such as play/pause, image contrast/brightness and image scaling. The system is capable of displaying two types of stored imagery. High quality JPEG compressed (Q-Factor 75 compression ratio approximately 15 to 1) digital cineloops and unaltered digital cine-loops. The JPEG images are intended for preview and preliminary assessment while the original data is always available on demand.
EchoNet Server: Unix workstation based database and image server software combined with a virtual file system. The server is a central archive for imagery and patient information. The EchoNet server may be configured with a variety of mass storage devices. These devices such as hard-disks, optical juke-box libraries and tape libraries provide on-line and archival storage of images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital ultrasound imaging systems
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
small departments (with 2 or 3 users) to large hospital networks (with tens of users).
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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) Summary
MAY - 7 1996
Identification of the Product
Trade Name: EchoNet Common Name: Unknown Classification Name: Device, Digital Image Storage
Manufacturer: Lockheed Martin Communication Systems 1 Federal Street (A&E 1C) Camden. NJ 08103 (609)338-3331 (609)338-2940 (FAX)
Contact Person: Vincent J. Napoleon
Date Prepared: 06 March 1996
Indications for Use:
EchoNet is software which runs on Unix workstations. EchoNet is intended to be used for storing and displaying digital imaqes acquired by digital ultrasound imaging systems. EchoNet provides rapid network access to the imagery and patient demographic data stored on a central server. The system retrieves and stores images as unaltered computer data and as JPEG (Joint Photographic Experts Group) lossy compressed cine-loops. This dual-path storage system allows for rapid access to high quality compressed images with the original unaltered (losslessly compressed) images available on demand. EchoNet is a scalable network system designed to service customers ranging in size from small departments (with 2 or 3 users) to large hospital networks (with tens of users).
Device Descriptions:
EchoNet is composed of the following:
Unix workstation which permits review and diagnosis of EchoNet Client: ultrasound imagery and demographics. This review software provides basic controls such as play/pause, image contrast/brightness and image scaling. The system is capable of displaying two types of stored imagery. High quality JPEG compressed (Q-Factor 75 compression ratio approximately 15 to 1) digital cineloops and unaltered digital cine-loops. The JPEG images are intended for preview and preliminary assessment while the original data is always available on demand.
1
EchoNet Server: Unix workstation based database and image server software combined with a virtual file system. The server is a central archive for imagery and patient information. The EchoNet server may be configured with a variety of mass storage devices. These devices such as hard-disks, optical juke-box libraries and tape libraries provide on-line and archival storage of images.
Marketing History
Lockheed Martin is about to begin marketing the EchoNet product. The EchoNet product, as to be marketed, is identical to the Heartlab EchoNet product described in a previous 510(k) submission with registration number K954860.
Potential Adverse Effects on Health
The potential concerns (data handling) are controlled by Failure Mode and Effects Analysis (FMEA) to identify required controls.
Conclusions
This system poses no added risk to safety.