Cleared Special

K031391 - HF MODULE WITH TRANSDUCERS

K031391 is an FDA 510(k) clearance for HF MODULE 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 49-day FDA review.

K031391 · Ophthalmic Technologies, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
49d
Days
Class 2
Risk

K031391 is an FDA 510(k) clearance for the HF MODULE 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 June 20, 2003 after a review of 49 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.

FDA 510(k) Submission Details - K031391

510(k) Number K031391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2003
Decision Date June 20, 2003
Days to Decision 49 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 107d · This submission: 49d
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

All 807
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K031391 · HF MODULE WITH TRANSDUCERS
Download PDF FDA Summary Ophthalmic Technologi…