Cleared Traditional

ADVANTX 1824 SPOTFILM DEVICE

K950317 · GE Medical Systems · Radiology
Feb 1995
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K950317 is an FDA 510(k) clearance for the ADVANTX 1824 SPOTFILM DEVICE, a Device, Spot-film (Class II — Special Controls, product code IXL), submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on February 8, 1995, 13 days after receiving the submission on January 26, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1670.

Submission Details

510(k) Number K950317 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1995
Decision Date February 08, 1995
Days to Decision 13 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IXL — Device, Spot-film
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1670

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