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510(k) Data Aggregation
K Number
K964460Device Name
THE ROBOLITE
Manufacturer
SHAI SYG MOTION AND INNOVATIONS, LTD.
Date Cleared
1997-01-24
(78 days)
Product Code
JQP
Regulation Number
862.2100Why did this record match?
Applicant Name (Manufacturer) :
SHAI SYG MOTION AND INNOVATIONS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ROBOLITE is an automatic needle guidance system that provides means for accurate positioning of a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions.
Device Description
The ROBOLITE is an automatic needle guidance system that provides means for accurate positioning of a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions. The ROBOLITE I S an attachment to and is mounted on a parent mammography system. It comprises a robotic biopsy unit and a film read out and motor control evaluation unit. After creating a stereotactic exposure of a previously detected breast lesion, the Robolite drives a needle holder along three orthogonal axes so that the needle penetrates the precise location of the lesion. The ROBOLITE can be used for fine for core biopsy by using the reqular needle aspiration (FNA) or carrier with a biopsy gun. needle with either plain film with a The ROBOLITE can be used X-ray or digital camera.
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K Number
K961849Device Name
THE ROBOGUIDE
Manufacturer
SHAI SYG MOTION AND INNOVATIONS, LTD.
Date Cleared
1996-08-21
(100 days)
Product Code
IZH
Regulation Number
892.1710Why did this record match?
Applicant Name (Manufacturer) :
SHAI SYG MOTION AND INNOVATIONS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
The ROBOGUIDE is an automatic needle guidanc system that provides means for accurate positioning of a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions. The Roboguide is an attachment to and is mounted on a parent mammography system. It comprises a robotic biopsy unit and a film read out and motor control evaluation unit. After creating a stereotactic exposure of a previously detected breast lesion, the Roboguide drives a needle holder along three orthogonal axes so that the needle penetrates the precise location of the lesion. The Roboguide can be used for fine needle aspiration (FNA) or tor core biopsy by interchanging its aspiration needle carrier with a biopsy gun holder carrier. The Roboguide can be used with either plain film X-ray or with a digital camera.
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