Cleared Traditional

K113403 - GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM

K113403 is an FDA 510(k) clearance for GE DISCOVERY IGS ANGIOGRAPHIC, manufactured by GE Medical Systems SCS. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K113403 · GE Medical Systems SCS · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
89d
Days
Class 2
Risk

K113403 is an FDA 510(k) clearance for the GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on February 14, 2012 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Medical Systems SCS devices

FDA 510(k) Submission Details - K113403

510(k) Number K113403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2011
Decision Date February 14, 2012
Days to Decision 89 days
Submission Type Traditional
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
18d faster than avg
Panel avg: 107d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWB Device Classification - Class 2, Special Controls

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
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 - OWB Interventional Fluoroscopic X-ray System

All 299
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K113403.
LESSRAY
K123226 · Saferay Spine, LLC · Dec 2012
OEC 9900 ELITE
K122234 · Ge Healthcare Surgery GE Oec Medical Systems, Inc. · Aug 2012
FLAT PANEL DETECTOR
K121444 · Canon, Inc. - Medical Equpment Group · Jun 2012
INFX-8000V WITH
K120073 · Toshibamedical Systems Corporation · Jan 2012
SYNGO AORTIC VALVEGUIDE SOFTWARE
K113027 · Siemens Medical Solutions USA, Inc. · Nov 2011
OEC(R) 9800, OEC(R) 9800 PLUS
K111551 · Ge Oec Medical Systems, Inc. · Oct 2011