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510(k) Data Aggregation
K Number
K013751Device Name
HANDHELD GAMMA FINDER (HGF)
Manufacturer
SILICON INSTRUMENTS GMHB
Date Cleared
2002-02-06
(85 days)
Product Code
IZD
Regulation Number
892.1320Why did this record match?
Applicant Name (Manufacturer) :
SILICON INSTRUMENTS GMHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SI Handheld Gamma Finder is indicated to detect and quantify the gamma photons in the body intra-operatively or extra-operatively, when gamma emitting radiopharmaceuticals are administered into the human body.
Device Description
The gamma-detector, energy discriminator, amplifier, controls and energy supply have been assembled into a single hand-held unit SI-Handheld Gamma Finder® (HGF), which is shielded by a biocompatible polymer. The probe's shape is conical; its shaft tapers off towards a tip that holds the collimator, the crystal and the PINdiode while a head of larger diameter houses the display, menu buttons, and other components. The device is held in one hand by the middle of the shaft. Outer diameters and weight are designed so as to allow single-handed use over periods of time longer than those of routine sentinel biopsies. The polymer casing of SI HGF is water resistant and thus allows extended cleansing with commercial surface disinfectants. The probe tip may even be immersed in disinfectants for several hours. This fulfills standard requirements of hospital hygiene. Disinfection of the probe is comparable to other, larger probes that are being used like Gamma Finder in conjunction with disposable sterile plastic covers. The HGF can be switched on or off by any key. Results are numerically shown in the liquid crystal display in counts per second (CPS), and updated every second. The HGF has only four keys. The currently measured value can be retained in the display for 5 seconds by pressing Key A. The HGF is packaged and transported in a small suitcase. The HGF can only be operated by a Sonnenschein Lithium Battery (SL2770/T), with a maximum charging current of 15 mA. It is not user replaceable. The display of the HGF will display an battery symbol, warning the user the battery life is approximately 20 hours from exhaustion. If the battery is exhausted, the display will show "LobAt". The only accessory is a Sterile Sleeve (No. SI-FOL-101) that accompanies each device, along with the User Manual.
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