Cleared Special

K032656 - GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X

K032656 is an FDA 510(k) clearance for GE LOGIQ 9 ULTRASOUND BT03/IQ, manufactured by Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc. The device is a Class 2 Radiology device with product code IYN cleared through the Special 510(k) pathway after a 63-day FDA review.

K032656 · Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
63d
Days
Class 2
Risk

K032656 is an FDA 510(k) clearance for the GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X. 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 Med. Systems Ultrasound & Prim. Care Diag.,Llc (Milwaukee, US). The FDA issued a Cleared decision on October 30, 2003 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc devices

FDA 510(k) Submission Details - K032656

510(k) Number K032656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2003
Decision Date October 30, 2003
Days to Decision 63 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 107d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

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

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