Cleared Traditional

K920373 - MAESTRO DIGITAL VIDEO SYSTEM

K920373 is an FDA 510(k) clearance for MAESTRO DIGITAL VIDEO SYSTEM, manufactured by International Imaging Electronics. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K920373 · International Imaging Electronics · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
147d
Days
Class 2
Risk

K920373 is an FDA 510(k) clearance for the MAESTRO DIGITAL VIDEO SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by International Imaging Electronics (Addison, US). The FDA issued a Cleared decision on June 24, 1992 after a review of 147 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all International Imaging Electronics devices

FDA 510(k) Submission Details - K920373

510(k) Number K920373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1992
Decision Date June 24, 1992
Days to Decision 147 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 107d · This submission: 147d
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 483
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K920373.
TRENDELENBURG ULTRASOUND TABLE, MODEL # 056-603
K922605 · Biodan Medical Systems, Ltd. · Oct 1992
CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER
K915715 · Ausonics Pty , Ltd. · Jul 1992
ACUSON IMAGE MANAGEMENT SYSTEM
K921670 · Acuson Corp. · Jun 1992
ALOKA 650CL DIAGNOSTIC ULTRASOUND SYSTEM
K920374 · Ge Medical Systems Information Technologies · Apr 1992
COMPUSCAN LT BIOMETRIC RULER AND IOL CALCULATOR
K910956 · Storz Instrument Co. · Sep 1991
SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
K910342 · Medison Co., Ltd. · Aug 1991