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510(k) Data Aggregation
K Number
K990416Device Name
OMNICORDER BIOSCAN SYSTEM
Manufacturer
Date Cleared
1999-12-23
(316 days)
Product Code
Regulation Number
884.2980Why did this record match?
Applicant Name (Manufacturer) :
OMNICORDER TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OmniCorder BioScan System is thermal camera based imaging device intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel who will determine when use of this device is indicated, based upon their professional assessment of the patient's medical condition. The patient populations include adult, pediatric and neonatal. The device is for adjunctive diagnostic screening for detection of breast cancer or other uses. This device is intended for use by qualified healthcare personnel trained in its use.
Device Description
The OmniCorder BioScan System is an infrared camera device which provides the capability for imaging and recording of thermal data radiating from adult, pediatric and neonatal patients in numerous hospital, nursing home and clinical settings; and in the home. It is a prescription device intended for use only by health care professionals.
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