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510(k) Data Aggregation
K Number
K092424Device Name
P-ART, MODEL 001Manufacturer
Date Cleared
2010-03-05
(210 days)
Product Code
Regulation Number
892.5050Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
P-ART, MODEL 001
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The P-ART device is designed to achieve patient correct geometric positioning with respect to a treatment device based on the specification of one or more successive treatment field prescriptions.
Device Description
Not Found
AI/ML Overview
This is a 510(k) clearance letter for the P-ART device, not a study report. The document indicates that the device has been found substantially equivalent to a predicate device but does not contain the detailed clinical study information requested. Therefore, I cannot provide a response to your request for acceptance criteria and study details based on the provided text.
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