Cleared Special

K092837 - OTI-SCAN 3000

K092837 is an FDA 510(k) clearance for OTI-SCAN 3000, manufactured by Opko Instrumentation, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Special 510(k) pathway after a 99-day FDA review.

K092837 · Opko Instrumentation, Inc. · Radiology device
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Dec 2009
Decision
99d
Days
Class 2
Risk

K092837 is an FDA 510(k) clearance for the OTI-SCAN 3000. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Opko Instrumentation, Inc. (Miami, US). The FDA issued a Cleared decision on December 23, 2009 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K092837

510(k) Number K092837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2009
Decision Date December 23, 2009
Days to Decision 99 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 107d · This submission: 99d
Pathway characteristics
Modification to existing cleared device.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

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K092837 · OTI-SCAN 3000
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