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510(k) Data Aggregation
K Number
K010772Device Name
ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM
Manufacturer
Date Cleared
2001-08-23
(162 days)
Product Code
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
IMAGING SERVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K955251Device Name
OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM
Manufacturer
Date Cleared
1996-04-12
(149 days)
Product Code
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
IMAGING SERVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Not Found
Device Description
The OEC 902 C-Arm frame, X-Ray Generator, X-Ray Control, Control Panel, Electrical Systems remain the same. Imaging Services, Inc. takes an OEC 902 and repaints it. We repair all mechanical brakes, replace the wheels with the new wheels rated for a greater weight, repair or replace motor drive assemblies with original or comparable replacement parts, repair all electronic systems, then calibrate the X-Ray generator to manufacture specifications using the OEC 902 Service Manual. Then we add a new 9/6 Image Intensifier and CCD Camera system. The CCD Camera System is calibrated to North American Imaging and Imaging Services Specifications. The ABS system utilizes original manufacturer's specifications, wiring and its electronic path remains the same. The wiring of the CCD Camera system uses original wires provided by the original camera system which was deinstalled. The interface between the C-Arm and monitor cart. also utilizes existing wiring as well as spares provided by OEC when the unit was originally manufactured.
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