Cleared Special

K101874 - GE LOGIQ P6/P6 PRO

K101874 is an FDA 510(k) clearance for GE LOGIQ P6/P6 PRO, manufactured by Ge Healthcare. The device is a Class 2 Radiology device with product code IYN cleared through the Special 510(k) pathway after a 95-day FDA review.

K101874 · Ge Healthcare · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
95d
Days
Class 2
Risk

K101874 is an FDA 510(k) clearance for the GE LOGIQ P6/P6 PRO. 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 Healthcare (Wauwatosa, US). The FDA issued a Cleared decision on October 5, 2010 after a review of 95 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K101874

510(k) Number K101874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2010
Decision Date October 05, 2010
Days to Decision 95 days
Submission Type Special
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
12d faster than avg
Panel avg: 107d · This submission: 95d
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

All 1187
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K101874 · GE LOGIQ P6/P6 PRO
Download PDF FDA Summary Ge Healthcare