Cleared Traditional

INTEGRATED REGISTRATION (K093234) - FDA 510(k) Clearance

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

K093234 · GE Medical Systems SCS · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
15d
Days
Class 2
Risk

K093234 is an FDA 510(k) clearance for the INTEGRATED REGISTRATION. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by GE Medical Systems SCS (Buc Cedex, FR). The FDA issued a Cleared decision on October 30, 2009 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all GE Medical Systems SCS devices

Submission Details

510(k) Number K093234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2009
Decision Date October 30, 2009
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 730
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K093234.
SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827
K100619 · Siemens Medical Solutions USA, Inc. · May 2010
STORM-BASE 2.0
K093603 · KARL STORZ Endoscopy-America, Inc. · Mar 2010
SYNGO.PET&CT ONCOLOGY
K093621 · Siemens Medical Solutions USA, Inc. · Feb 2010
SYNGO TRUED
K091373 · Siemens Medical Solutions USA, Inc. · May 2009
SYNGOCIRCULATION DYNAMICPET, VERSION 1.0
K083327 · Siemens Medical Solutions USA, Inc. · May 2009
SYNGO US WORKPLACE
K091286 · Siemens Medical Solutions USA, Inc. · May 2009