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510(k) Data Aggregation
K Number
K092713Device Name
SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM
Manufacturer
Date Cleared
2010-07-16
(316 days)
Product Code
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
TRANSAMERICAN MEDICAL IMAGING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Spectre System is intended for use with compatible diagnostic x-ray systems in hospitals or outpatient facilities. The Spectre System is indicated for use as an accessory to provide input control to compatible x-ray systems. This accessory includes a wireless footswitch, a wireless hand switch, and a receiver. It is cleared for use for the particular indications of the x-ray system to which it is attached.
Device Description
The Spectre System is an alternate option to the existing cabled foot switch and hand switch for users of Xray systems. It consists of three parts-a footswitch/transmitter, a hands switch/transmitter, and a receiver. The Spectre system receiver connects to the x-ray system through the same connector as the current footswitch, and operates the x-ray system by exactly emulating the functionality of the current cabled footswitch and hand switch. There are no cables, therefore, no trip hazards, contamination hazards, or cable breakage hazards. The footswitch and hand switch are powered by batteries, eliminating shock hazards. The receiver is mounted on the predicate device, and is powered from the predicate device.
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