Cleared Traditional

K910342 - SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAG...

K910342 is an FDA 510(k) clearance for SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAG..., manufactured by Medison Co., Ltd.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K910342 · Medison Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1991
Decision
203d
Days
Class 2
Risk

K910342 is an FDA 510(k) clearance for the SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Medison Co., Ltd. (Kang Won-Do, KR). The FDA issued a Cleared decision on August 19, 1991 after a review of 203 days - an extended review 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: 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 Medison Co., Ltd. devices

FDA 510(k) Submission Details - K910342

510(k) Number K910342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1991
Decision Date August 19, 1991
Days to Decision 203 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 107d · This submission: 203d
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 448
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K910342.
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
ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9)
K903603 · Advanced Technology Laboratories, Inc. · Feb 1991
EUB-315
K905294 · Hitachi Medical Corp. of America · Feb 1991
EUB-565 DIAGNOSTIC ULTRASOUND DEVICE
K896100 · Hitachi Medical Corp. of America · Jan 1991