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510(k) Data Aggregation
K Number
K974504Device Name
EPS
Manufacturer
E FOR M IMAGING SYSTEMS DIV., MARQUETTE ELECTRONIC
Date Cleared
1998-02-27
(88 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
E FOR M IMAGING SYSTEMS DIV., MARQUETTE ELECTRONIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EPS system is a digital recording system designed for use as an electronic photospot device on OEM manufactured Radiographic & Fluoroscopic ("R/F") systems. The system is modular in configuration allowing single and dual room configurations for acquisition and/or review, providing assistance to Radiologic Technologists in routine diagnostic examinations and special procedures in R/F. The EPS system may be used to acquire, display, record, archive, and disseminate digital R/F image data.
Device Description
The Electronic PhotoSpot (EPS) is a 10 bit PC based multitasking acquisition/display system configured for use in R/F applications. This system is designed for use by a qualified Radiologic Technologist. More specifically, the EPS system is a digital recording system designed for use as an electronic photospot device on OEM manufactured R/F systems. This system consists of independent and simultaneous acquisition of data, review, post processing of raw data and archive transfer functions. The system is modular in configuration allowing single and dual room configurations for acquisition and/or review. The system has 10 bit, 1024 digital acquisition, display and storage capability and uses a Windows based operator interface on the Operator Console/Review Station. It includes the following major components (minimally): Pentium computers, Image monitor(s), Camera X-Ray Interface, MOD media for archival, Software program developed by Marquette Medical Systems to run in conjunction with Microsoft Windows NT. The EPS provides image acquisition, display, archival, and exchange media compliant with the DICOM 3.0 standard. Furthermore, the EPS allows connection to the medical facility's existing LAN network for data dissemination to support reviews, reports, and patient billing.
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K Number
K955184Device Name
ACCULUPE
Manufacturer
E FOR M IMAGING SYSTEMS DIV., MARQUETTE ELECTRONIC
Date Cleared
1996-01-24
(72 days)
Product Code
LMB
Regulation Number
892.2010Why did this record match?
Applicant Name (Manufacturer) :
E FOR M IMAGING SYSTEMS DIV., MARQUETTE ELECTRONIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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