Cleared Traditional

K880081 - VISION CARE/PHAKOSYSTEMS ECHOPACH

K880081 is an FDA 510(k) clearance for VISION CARE/PHAKOSYSTEMS ECHOPACH, manufactured by Phakosystems, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K880081 · Phakosystems, Inc. · Radiology device
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Mar 1988
Decision
64d
Days
Class 2
Risk

K880081 is an FDA 510(k) clearance for the VISION CARE/PHAKOSYSTEMS ECHOPACH. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Phakosystems, Inc. (Canada, CA). The FDA issued a Cleared decision on March 15, 1988 after a review of 64 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Phakosystems, Inc. devices

FDA 510(k) Submission Details - K880081

510(k) Number K880081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1988
Decision Date March 15, 1988
Days to Decision 64 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 670
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