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510(k) Data Aggregation
K Number
K092837Device Name
OTI-SCAN 3000
Manufacturer
OPKO INSTRUMENTATION, INC
Date Cleared
2009-12-23
(99 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
OPKO INSTRUMENTATION, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OTI-Scan 3000 ultrasound system is a multi-purpose personal-computer based ultrasonic diagnosis system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including measurement of the axial length for determination of IOL power.
Device Description
The OTI-Scan 3000 is an Ultrasonic ophthalmic A-Scan and B-Scan system that uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes and to visualize the interior of the eye.
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