Search Results
Found 1 results
510(k) Data Aggregation
K Number
K963730Device Name
PROTEC (1024)
Manufacturer
Date Cleared
1997-02-10
(147 days)
Product Code
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
PROPORTIONAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
imaging human organs through use of injected radiopharmaceuticals, which are separately regulated as diagnostic drugs. The device will have a wide variety of applications in planar single organ and whole body imaging.
Device Description
The Protec-1024 is an imaging device utilized to determine the distribution of gammaemitting radioactive tracers within the human body. The device consists of a radiation detection head, containing a multiwire proportional detector, coupled to a mobile part, containing electronics utilized to process images from the detector, and a computer utilized to control image acquisition and to provide image processing and display.
Ask a Question
Ask a specific question about this device
Page 1 of 1