Cleared Traditional

LOGIQ E (K133533) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K133533 · Ge Healthcare · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
86d
Days
Class 2
Risk

K133533 is an FDA 510(k) clearance for the LOGIQ E. 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 February 12, 2014 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ge Healthcare devices

Submission Details

510(k) Number K133533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2013
Decision Date February 12, 2014
Days to Decision 86 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 107d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 535
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K133533.
ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems
K142876 · Siemens Medical Solutions USA, Inc. · Oct 2014
ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM
K141846 · Siemens Medical Solutions USA, Inc. · Aug 2014
ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
K140959 · Siemens Medical Solutions USA, Inc. · Apr 2014
ACUSON
K131164 · Siemens Medical Solutions USA, Inc. · Dec 2013
SITE-RITE VISION II ULTRASOUND SYSTEM
K132942 · C.R. Bard, Inc. · Oct 2013
ACUSON S2000 AND S3000
K130881 · Siemens Medical Solutions USA, Inc. · Oct 2013