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510(k) Data Aggregation
K Number
K051734Device Name
GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955
Manufacturer
Date Cleared
2005-11-23
(148 days)
Product Code
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
GE HEALTHCARE TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GE Healthcare Navigation and Visualization System [InstaTrak® 3500 Plus System or FluoroTrak™ 9800 Plus System] together with the Axcess™ Bone Pin, is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotaxic surgery and which provides a reference to rigid structures such as sinus, skull, long bone or vertebra visible on medical images such as CT, MR or x-ray,
The Axcess™ Bone Pin is to be used where rigid fixation of a tracking device to bone is required.
Device Description
The GE Healthcare Navigation and Visualization System [InstaTrak® 3500 Plus System or FluoroTrak™ 9800 Plus System] together with the Axcess™ Bone Pin. The Axcess™ Bone Pin is one example of the Axcess™ Bone Pin.
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K Number
K042866Device Name
AMX5 AND AMX5D MOBILE X-RAY SYSTEMS
Manufacturer
Date Cleared
2004-11-02
(15 days)
Product Code
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
GE HEALTHCARE TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AMX5 and AMX5D are indicated for use in generating radiographic images of human anatomy in all general purpose X-ray diagnostic procedures. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, pediatrics, orthopedics, and clinics.
Device Description
The AMX5 is a power driven mobile unit including an X-ray generator, X-ray tube, and beam limiting device, along with control electronics for the drive mechanism, and embedded software. The AMX5D is the same as the AMX5 but is used in conjunction with a portable digital X-ray detector.
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