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510(k) Data Aggregation
K Number
K010792Device Name
MAMMOGRAPH
Manufacturer
Date Cleared
2001-04-03
(18 days)
Product Code
Regulation Number
892.1710Why did this record match?
Applicant Name (Manufacturer) :
DIGITEC MEDICAL SERVICE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K993681Device Name
DIGITEC TWO STAGE COMPRESSION KIT
Manufacturer
Date Cleared
1999-12-21
(50 days)
Product Code
Regulation Number
892.1710Why did this record match?
Applicant Name (Manufacturer) :
DIGITEC MEDICAL SERVICE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Digitec Two Stage Compression Kit is a modification for the GE Senographe 600T series x-ray mammography systems. It modifies two aspects of the compression system.
First, the kit is intended to improve the "fine adjustment" control of the compression sequence. The original design of the compression system uses the same control method for applying initial compression force and for "fine adjustment" force. The kit does not change the method to apply initial compression force. It modifies the control sequence to achieve smoother fine adjustment control. "Fine adjustment" control is required to slowly and incrementally add the last little bit of compression just prior to making the exposure.
The modification kit also repositions the compression paddle to be flat and parallel with the breast support plate. The original design elevates the chestwall edge of the compression paddle off of the breast support plate. The kit removes the 1.2-degree tilt of the original design.
The kit is not intended to change the basic operation of the compression system, the operator controls, or the amount of compression force applied to the breast. Finally, the kit does not change the safety or compression release features in any way.
Device Description
The Digitec Two Stage Compression Kit is an accessory item designed for use in the GE Senographe 600T series X-Ray Mammography Systems. It is comprised of two parts:
- 1) Compression Control Module
The compression control module is a small electrical circuit added to the original compression control system. It modifies the system to give the technologist a smoother method for applying "fine adjustment" compression force.
- 2) Paddle Leveling Spacers
The leveling spacers are used to change the position of the compression paddles relative to the bucky surface. The spacers are small aluminum pieces designed to fit on the compression paddle mounting arms. The spacers remove the 1.2 degree tilt of the original design and reposition the paddles flat and parallel with the surface of the bucky.
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