Cleared Traditional

K792638 - HIGH RESOLUTION IMAGING SYSTEM

K792638 is an FDA 510(k) clearance for HIGH RESOLUTION IMAGING SYSTEM, manufactured by Unirad Corp.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K792638 · Unirad Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1980
Decision
39d
Days
Class 2
Risk

K792638 is an FDA 510(k) clearance for the HIGH RESOLUTION IMAGING SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Unirad Corp. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1980 after a review of 39 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 Unirad Corp. devices

FDA 510(k) Submission Details - K792638

510(k) Number K792638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1979
Decision Date January 28, 1980
Days to Decision 39 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 107d · This submission: 39d
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 671
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K792638.
S.K. DIAG. ULTRASOUND BODY SCANNER
K800532 · Smithkline Diagnostics, Inc. · Apr 1980
ECHO-OCULOMETER #3000
K791766 · Jedmed Instrument Co. · Feb 1980
SEARLE PHO/SONIC ALPHA 2000
K800139 · G.D. Searle and Co. · Feb 1980
SMV 120 SONIC MAMMOGRAPHIC VIEWER
K792585 · Johnson & Johnson Professionals, Inc. · Jan 1980
OCTOSON
K792388 · Ausonics Pty , Ltd. · Dec 1979
VARIAN V-3400, PHASED ARRAY ULTRASON
K791744 · Varian Assoc., Inc. · Oct 1979