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510(k) Data Aggregation
K Number
K081858Device Name
RETCAM 3 OPHTHALMIC IMAGING SYSTEMManufacturer
Date Cleared
2008-11-05
(127 days)
Product Code
Regulation Number
886.1120Type
TraditionalPanel
OphthalmicReference & Predicate Devices
N/A
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Device Name :
RETCAM 3 OPHTHALMIC IMAGING SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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