Cleared Special

K030770 - OTI SCAN WITH TRANSDUCERS

K030770 is an FDA 510(k) clearance for OTI SCAN WITH TRANSDUCERS, manufactured by Ophthalmic Technologies, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Special 510(k) pathway after a 16-day FDA review.

K030770 · Ophthalmic Technologies, Inc. · Radiology device
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Mar 2003
Decision
16d
Days
Class 2
Risk

K030770 is an FDA 510(k) clearance for the OTI SCAN WITH TRANSDUCERS. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Ophthalmic Technologies, Inc. (Hasbrouck, US). The FDA issued a Cleared decision on March 27, 2003 after a review of 16 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ophthalmic Technologies, Inc. devices

FDA 510(k) Submission Details - K030770

510(k) Number K030770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2003
Decision Date March 27, 2003
Days to Decision 16 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 107d · This submission: 16d
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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