Cleared Traditional

INNOVA 3100

K031637 · GE Medical Systems · Radiology

Aug 2003

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K031637 is an FDA 510(k) clearance for the INNOVA 3100, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on August 22, 2003, 87 days after receiving the submission on May 27, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K031637 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2003
Decision Date	August 22, 2003
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

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