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510(k) Data Aggregation
K Number
K984405Device Name
ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000
Manufacturer
INTRACOM CORP.
Date Cleared
1999-02-08
(61 days)
Product Code
LMB
Regulation Number
892.2010Why did this record match?
Applicant Name (Manufacturer) :
INTRACOM CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EchoLive™ medical image management device family is designed for use in all medical specialties including, but not limited to, radiology, cardiology, gynecology, ENT, neurology, pediatrics, podiatry, chiropractic, general surgery, oral surgery and dentistry. The device may be used in medical offices and health care facilities, to facilitate access to clinical images and information, both archived and dynamic, in distributed locations over intranets, LANs, Internet, direct or dial dial-up telephone lines. The system may transmit a wide range of data including, but not limited to, Sonographs (Ultrasound images), Computer Tomography (CT), Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET). In addition the device may communicate standard audio, video and digital transmissions and recordings, providing complete clinical imaging handling, providing direct capture, retrieval, storage, and direct transmission and printing of images, reports, and patient information.
Device Description
The EchoLive™ medical image management device family is a PACS capable of digital real-time simulcast transmission of medical images. Each model varies in the particular features and capabilities it offers the medical professional.
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