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510(k) Data Aggregation
K Number
K062788Device Name
COLLIMATOR, MODEL M-38
Manufacturer
UMI INTERNATIONAL
Date Cleared
2006-12-28
(101 days)
Product Code
KPW
Regulation Number
892.1610Why did this record match?
Applicant Name (Manufacturer) :
UMI INTERNATIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A diagnostic x-ray beam-limiting device intended to restrict the dimension of a diagnostic x-ray field by limiting the size of the primary x-ray beam coming from x-ray system.
Device Description
Collimator (manual drive) – a beam limiting device
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