Cleared Traditional

K022154 - LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D

K022154 is an FDA 510(k) clearance for LEVEL 356 X-RAY FILM PROCESSOR, manufactured by Fischer Industries, Inc.. The device is a Class 2 Radiology device with product code IXW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K022154 · Fischer Industries, Inc. · Radiology device
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Sep 2002
Decision
90d
Days
Class 2
Risk

K022154 is an FDA 510(k) clearance for the LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D. Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by Fischer Industries, Inc. (Geneva, US). The FDA issued a Cleared decision on September 30, 2002 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1900 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fischer Industries, Inc. devices

FDA 510(k) Submission Details - K022154

510(k) Number K022154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2002
Decision Date September 30, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXW Device Classification - Class 2, Special Controls

Product Code IXW Processor, Radiographic-film, Automatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1900
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 - IXW Processor, Radiographic-film, Automatic

All 51
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K022154.
XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT
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FREEDOM AUTOMATIC FILM PROCESSOR
K002640 · J. Morita USA, Inc. · Nov 2000
OPTIMAX/ COMPACT 2
K992818 · Protec GmbH & Co. KG · Sep 1999
KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR
K990969 · Konica Medical Corp. · Jun 1999
AII-PRO 100 PLUS AND ALL-PRO 200
K991435 · All-Pro Imaging Corp. · May 1999
CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS
K981280 · Bayer Corp., Agfa Div. · Apr 1998