(74 days)
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No
The summary describes a system for acquiring, viewing, and archiving echocardiogram images, with no mention of AI or ML capabilities for image analysis or interpretation.
No
The device is described as a system for acquiring, viewing, storing, and retrieving echocardiogram images, not for treating any condition. Its intended use is diagnostic image management rather than therapeutic intervention.
No
The device is described as a "network system intended to use digital technology to acquire images from an echocardiography ultrasound system for viewing outside the exam room and long term storage and retrieval on digital media." It is for "review of echocardiograms" and archiving. While it handles medical images, its stated function is for viewing, storage, and retrieval, rather than providing a diagnosis based on those images.
No
The device description explicitly states it is comprised of three major subsystems: the Image Acquisition Unit (IAU), the Workstation, and the Archive Subsystem. These components suggest hardware is involved beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for acquiring, viewing, storing, and retrieving images from an echocardiography ultrasound system. This is related to medical imaging and data management, not the analysis of biological samples in vitro (outside the body).
- Device Description: The description details a network system for reviewing and archiving echocardiograms. This aligns with image management and review, not in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to perform tests on samples such as blood, urine, tissue, etc., to provide information for diagnosis, monitoring, or screening. This device's function is centered around managing medical images.
N/A
Intended Use / Indications for Use
The UNIVISION™ Echocardiology System is a network system intended to use digital technology to acquire images from an echocardiogaphy ultrasound system for viewing outside the exam room and long term storage and retrieval on digital media. The substantial equivalent device is TomTec Imaging Systems' TomTec P90 system, FDA 510K Number K950279.
Product codes
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Device Description
UNIVISION™ Echocardiology System is a real-time network system that provides review of echocardiograms either inside or outside the hospital environment. The exams are then archived on optical disc media. The UNIVISION™ Echocardiology System is comprised of three major subsystems: the Image Acquisition Unit (IAU); the Workstation; and the Archive Subsystem.
· The Image Acquisition Unit (IAU) interfaces to a variety of ultrasound systems and obtains the patient's information and image data during exams. This information is stored locally on the IAU for access anywhere on the network.
• Workstations provide the review of either exams in progress or previous exams that may be stored anywhere on the network.
· The Archive Subsystem consists of a jukebox server and CD-R (Compact Disc - Recordable) for archive of the echocardiology exams.
All image transfers over the network and on-and-off the CD-R jukebox employ the MPEG-1 (ISO/IEC 11172) standard for video and audio compression at a 30:1 compression ratio,
The UNIVISION™ Echocardiology System is a network system that uses digital technology to acquire images from an echocardiography ultrasound system. The images may be viewed outside the exam room and are stored and retrieved on digital media. The substantially equivalent device is TomTec Imaging Systems', TomTec P90 system, FDA 510K Number K950279.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Echocardiogaphy ultrasound system
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
The UNIVISION™ Echocardiology System is intended for use in ultrasound Echocardiology laboratories.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.2010 Medical image storage device.
(a)
Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
FEB 1 1 1997
PREMARKET NOTIFICATION SUMMARY UNIVISION™ ECHOCARDIOLOGY SYSTEM Network Concepts, Inc.
SUBMITTER:
Larry Sieb Division Manager, Cardiology, NetworkConcepts, Inc. 2135 W. Greenview Drive Middleton. WI 53562
Tel: (608) 836-9334 Fax: (608) 831-8333
DEVICE NAME:
Classification: Class II
Common/Usual Name: Mini-Pacs (Picture Archiving and Communications System): Image Management System
Proprietary Name: UNIVISION™ Echocardiology System
INTENDED USE:
The UNIVISION™ Echocardiology System is a network system intended to use digital technology to acquire images from an echocardiogaphy ultrasound system for viewing outside the exam room and long term storage and retrieval on digital media. The substantial equivalent device is TomTec Imaging Systems' TomTec P90 system, FDA 510K Number K950279.
DEVICE DESCRIPTION:
UNIVISION™ Echocardiology System is a real-time network system that provides review of echocardiograms either inside or outside the hospital environment. The exams are then archived on optical disc media. The UNIVISION™ Echocardiology System is comprised of three major subsystems: the Image Acquisition Unit (IAU); the Workstation; and the Archive Subsystem.
· The Image Acquisition Unit (IAU) interfaces to a variety of ultrasound systems and obtains the patient's information and image data during exams.
1
This information is stored locally on the IAU for access anywhere on the network.
• Workstations provide the review of either exams in progress or previous exams that may be stored anywhere on the network.
· The Archive Subsystem consists of a jukebox server and CD-R (Compact Disc - Recordable) for archive of the echocardiology exams.
All image transfers over the network and on-and-off the CD-R jukebox employ the MPEG-1 (ISO/IEC 11172) standard for video and audio compression at a 30:1 compression ratio,
The UNIVISION™ Echocardiology System is a network system that uses digital technology to acquire images from an echocardiography ultrasound system. The images may be viewed outside the exam room and are stored and retrieved on digital media. The substantially equivalent device is TomTec Imaging Systems', TomTec P90 system, FDA 510K Number K950279.
COMPARISONS TO PREDICATE DEVICE:
The substantially equivalent device is TomTec Imaging Systems', TomTec P90 system, FDA 510K Number K950279. The TomTec P90 has several options. The TomTec P90 configuration that is equivalent to the UNIVISION™ Echocardiology System includes the Stress Echo and Networking application packages. The TomTec 3D/4D Ultrasound and Contrast Densitometry applications are not functions implemented in the UNIVISION™ Echocardiology System.
The UNIVISION™ Echocardiology System is intended for use in ultrasound Echocardiology laboratories. It acquires echocardiograms from ultrasound imaging systems during the exam and transmits these over a network for review and archive onto CD-R optical discs.
To increase speed of transmission over the network and make storage economically viable. MPEG-1 compression is employed. The images show no significant difference between the original image from an ultrasound echocardiology system and that from the same image after MPEG-1 compression has been employed.
CONCLUSION:
The UNIVISION™ Echocardiology System is substantially equivalent to the legally marketed predicate device with regards to safety, effectiveness and intended use.