Cleared Abbreviated

K023801 - FILM PROCESSOR, MODEL LIFE RAY PRO 1000

K023801 is an FDA 510(k) clearance for FILM PROCESSOR, manufactured by S.A.I.E.P. S.R.L.. The device is a Class 2 Radiology device with product code IXW cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K023801 · S.A.I.E.P. S.R.L. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
90d
Days
Class 2
Risk

K023801 is an FDA 510(k) clearance for the FILM PROCESSOR, MODEL LIFE RAY PRO 1000. Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by S.A.I.E.P. S.R.L. (Weatherford, US). The FDA issued a Cleared decision on February 12, 2003 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K023801

510(k) Number K023801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2002
Decision Date February 12, 2003
Days to Decision 90 days
Submission Type Abbreviated
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
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

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 82
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K023801.
INTRAX FILM PROCESSOR
K093503 · Velopex International, Inc. · Jan 2010
OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX
K091628 · Protec GmbH & Co. KG · Aug 2009
RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000
K024342 · Daito Co., Ltd. · Apr 2003
FILM PROCESSOR, MODEL LIFE RAY PRO 2500
K023825 · S.A.I.E.P. S.R.L. · Feb 2003
AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036
K023613 · Alphatek Corp. · Jan 2003
LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D
K022154 · Fischer Industries, Inc. · Sep 2002
K023801 · FILM PROCESSOR, MODEL LIFE RAY PRO 1000
Download PDF FDA Summary S.A.I.E.P. S.R.L.