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510(k) Data Aggregation
K Number
K962615Device Name
TUMORLOCALIZER MRI
Manufacturer
FERGUSON MEDICAL
Date Cleared
1998-03-19
(624 days)
Product Code
MIG
Regulation Number
N/AWhy did this record match?
Product Code :
MIG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for use to identify by standard radiologic mark or techniques (X-Ray, fluoroscopy, CT, MRI) the location of a soft tissue abnormality such as a cyst, lesion, or tumor.
Device Description
The TumorLocalizer MRI is a standard needle and hookwire device used for the localization of non-palpable lesions.
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