Cleared Traditional

K960700 - LOGIQ A200 DIAGNOSTIC ULTRASOUND SYSTEM

K960700 is an FDA 510(k) clearance for LOGIQ A200 DIAGNOSTIC ULTRASOUND SYSTEM, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K960700 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
190d
Days
Class 2
Risk

K960700 is an FDA 510(k) clearance for the LOGIQ A200 DIAGNOSTIC ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on August 28, 1996 after a review of 190 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 GE Medical Systems devices

FDA 510(k) Submission Details - K960700

510(k) Number K960700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1996
Decision Date August 28, 1996
Days to Decision 190 days
Submission Type Traditional
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
83d slower than avg
Panel avg: 107d · This submission: 190d
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 452
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K960700.
ULTRASOUND SYSTEM MODEL UF-3500
K955543 · Fukuda Denshi USA, Inc. · Feb 1997
VINGMED SOUND COLOR FLOW MAPPING SYSTEM
K962662 · Diasonics, Inc. · Jan 1997
SONOLINE ELEGRA WITH SIESCAPE FEATURE
K961833 · Siemens Medical Solutions USA, Inc. · Oct 1996
EUB-905
K962308 · Hitachi Medical Corp. of America · Jul 1996
DIAGNOSTIC ULTRASONIC TRANSDUCER
K941593 · Toshiba America Medical Systems, In.C · May 1996
OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER
K951994 · Olympus America, Inc. · Apr 1996