Cleared Traditional

ADVANTX 1824 SPOTFILM DEVICE (K950317) - FDA 510(k) Clearance

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

K950317 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
13d
Days
Class 2
Risk

K950317 is an FDA 510(k) clearance for the ADVANTX 1824 SPOTFILM DEVICE. Classified as Device, Spot-film (product code IXL), Class II - Special Controls.

Submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on February 8, 1995 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1670 - 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 devices

Submission Details

510(k) Number K950317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 107d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IXL Device, Spot-film
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1670
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 - IXL Device, Spot-film

Devices cleared under the same product code (IXL) and FDA review panel - the closest regulatory comparables to K950317.
KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP
K940386 · Eastman Kodak Company · Aug 1994
DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4
K924593 · Philips Medical Systems, Inc. · Nov 1992
SPOT-FILM DEVICE 8835
K842184 · General Electric Co. · Jul 1984
MULTI-FORMAT SFD MODEL 1720
K800554 · Philips Medical Systems (Cleveland), Inc. · Apr 1980