Cleared Traditional

K964886 - GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM

K964886 is an FDA 510(k) clearance for GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K964886 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
235d
Days
Class 2
Risk

K964886 is an FDA 510(k) clearance for the GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on July 29, 1997 after a review of 235 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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 - K964886

510(k) Number K964886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1996
Decision Date July 29, 1997
Days to Decision 235 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
128d slower than avg
Panel avg: 107d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 889
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K964886.
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING
K980557 · Siemens Medical Solutions USA, Inc. · Apr 1998
LOGIQ 1000 DIAGNOSTIC ULTRSOUND SYSTEM
K960527 · GE Medical Systems · Sep 1997
ALOKA SSD-1400 DIAGNOSTIC ULTRASOUND SYSTEM
K972465 · Aloka Co., Ltd. · Aug 1997
EUB-8000
K954220 · Hitachi Medical Corp. of America · May 1997
SONOS 2000, SONOS 2500 (M2406 A)
K964309 · Hewlett-Packard Co. · Apr 1997
ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM
K963616 · Aloka Co., Ltd. · Apr 1997