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510(k) Data Aggregation
K Number
K002724Device Name
NUMALINK
Manufacturer
Date Cleared
2000-11-17
(78 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NUMA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K974444Device Name
NUMASTATION
Manufacturer
Date Cleared
1998-02-13
(80 days)
Product Code
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
NUMA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NumaStation is a stand-alone computer interface that connects to third party gamma cameras and acquires data and transfers that data to a processing computer, it is used in planar and whole-body and SPECT imaging.
Device Description
The NumaStation is a stand-alone computer interface that connects to third party gamma cameras and acquires data and transfers that data to a processing computer. The acquisition hardware is a microprocessor-based system and is separate from the host personal computer. It uses simple, window-based GUIs.
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