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510(k) Data Aggregation
K Number
K011155Manufacturer
Date Cleared
2001-07-12
(87 days)
Product Code
Regulation Number
892.5730Type
AbbreviatedPanel
RadiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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