HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA

System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS F.I. HAIFA

The following data is part of a premarket notification filed by Ge Medical Systems F.i. Haifa with the FDA for Hawkeye Option For Dual-head Variable Angle Gamma Camera.

Pre-market Notification Details

Device IDK991841
510k NumberK991841
Device Name:HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
ClassificationSystem, Tomography, Computed, Emission
Applicant GE MEDICAL SYSTEMS F.I. HAIFA P.O. BOX 170 Tirat Hacarmel,  IL 30200
ContactDan Laor
CorrespondentDan Laor
GE MEDICAL SYSTEMS F.I. HAIFA P.O. BOX 170 Tirat Hacarmel,  IL 30200
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-28
Decision Date1999-08-26
Summary:summary

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