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510(k) Data Aggregation
K Number
K032471Device Name
TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM
Manufacturer
TITRONICS RESEARCH & DEVELOPMENT CO.
Date Cleared
2003-10-10
(60 days)
Product Code
LHQ
Regulation Number
884.2980Why did this record match?
Applicant Name (Manufacturer) :
**TITRONICS RESEARCH **& DEVELOPMENT CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TyTron C-500IR Clinical Infrared Imaging System is intended for adjunctive diagnostic screening for the detection of breast cancer and other uses such as: peripheral vascular disease, neuromusculoskeletal disorders, extracranial cerebral and facial vascular disease, thyroid gland abnormalities, and various other neoplastic, metabolic, and inflammatory conditions. Use of the TyTron C-500IR System is not intended to be the sole diagnostic procedure for these diseases and conditions.
Device Description
The TyTron C-500IR is a non-contact, non-invasive, non-radiating, thermal (infrared) imaging system composed of an infrared camera which is interfaced to a computer with the intent of viewing and digitally storing thermal patterns generated by the surface of the human body.
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K Number
K974208Device Name
TYTRON C-3000
Manufacturer
TITRONICS RESEARCH & DEVELOPMENT CO.
Date Cleared
1998-02-03
(85 days)
Product Code
HCS
Regulation Number
882.1570Why did this record match?
Applicant Name (Manufacturer) :
**TITRONICS RESEARCH **& DEVELOPMENT CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TyTron C-3000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by professional health care providers. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care.
Device Description
The TyTron C-3000 is a hand held paraspinal thermographic scanning system. It consists of two probes which each contain infrared sensors designed to be placed on either side of the spinal column to detect temperatures. With the aid of a computer assisted program the system is capable of recording and graphing thermal differentials (right to left thermal asymmetries) on a horizontal scale. It also records direct temperatures on the vertical scale.
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