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Found 3 results
510(k) Data Aggregation
K Number
K964327Device Name
IPU RX-2Manufacturer
Date Cleared
1997-01-17
(79 days)
Product Code
Regulation Number
892.2050Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
MEDIREX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K965013Device Name
DIGISCOPE RX-2 (9 OPTION)Manufacturer
Date Cleared
1997-01-17
(32 days)
Product Code
Regulation Number
892.1650Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
MEDIREX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K960198Device Name
DIGISCOPE RX-2Manufacturer
Date Cleared
1996-03-12
(56 days)
Product Code
Regulation Number
892.1650Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
MEDIREX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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