Cleared Special

Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR

K232344 · GE Medical Systems SCS · Radiology

Oct 2023

Decision

68d

Days

Class 2

Risk

About This 510(k) Submission

K232344 is an FDA 510(k) clearance for the Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on October 11, 2023, 68 days after receiving the submission on August 4, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K232344 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 2023
Decision Date	October 11, 2023
Days to Decision	68 days
Submission Type	Special
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