Cleared Special

K014206 - LOGIQBOOK

K014206 is an FDA 510(k) clearance for LOGIQBOOK, manufactured by General Electric Co.. The device is a Class 2 Radiology device with product code IYO cleared through the Special 510(k) pathway after a 26-day FDA review.

K014206 · General Electric Co. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
26d
Days
Class 2
Risk

K014206 is an FDA 510(k) clearance for the LOGIQBOOK. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on January 16, 2002 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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.

FDA 510(k) Submission Details - K014206

510(k) Number K014206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2001
Decision Date January 16, 2002
Days to Decision 26 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
81d faster than avg
Panel avg: 107d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 897
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K014206.
ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS
K013088 · Echotech 3D Imaging Systems, Inc. · Apr 2002
SONOREAL 3D SYSTEM
K020068 · Bio Medi Com · Mar 2002
HUMPHREY OCT3
K012727 · Carl Zeiss Ophthalmic Systems, Inc. · Jan 2002
CTS-415
K013327 · Shantou Institute of Ultrasonic Instuments · Dec 2001
SSA-770A, APLIO ULTRASOUND SYSTEM
K013633 · Toshiba America Medical Systems, In.C · Nov 2001
DIASUS
K013142 · Dynamic Imaging , Ltd. · Oct 2001
K014206 · LOGIQBOOK
Download PDF FDA Summary General Electric Co.