Search Results
Found 1 results
510(k) Data Aggregation
K Number
K093706Device Name
PROXISCAN MODEL 101
Manufacturer
Date Cleared
2010-04-02
(122 days)
Product Code
Regulation Number
892.1100Why did this record match?
Applicant Name (Manufacturer) :
HYBRIDYNE IMAGING TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ProxiScan™ is indicated for use in imaging the distribution of radionuclides in the human body using planar imaging techniques. ProxiScan™ may also be used intraoperatively, on pathological specimens and for endocavity applications if a protective sheath is used.
Device Description
The ProxiScan™ is an imaging device consisting of the imaging system: detector module, high-voltage power supply and computer. The detector module and highvoltage power supply are integrated into a small handheld enclosure, which works in conjunction with an external low-voltage power supply and a computer for data acquisition and processing.
Ask a Question
Ask a specific question about this device
Page 1 of 1