Cleared Traditional

K024342 - RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000

K024342 is an FDA 510(k) clearance for RADIOGRAPHIC FILM PROCESSOR, manufactured by Daito Co., Ltd.. The device is a Class 2 Radiology device with product code IXW cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K024342 · Daito Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
117d
Days
Class 2
Risk

K024342 is an FDA 510(k) clearance for the RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000. Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by Daito Co., Ltd. (Manchester, US). The FDA issued a Cleared decision on April 23, 2003 after a review of 117 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.

FDA 510(k) Submission Details - K024342

510(k) Number K024342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2002
Decision Date April 23, 2003
Days to Decision 117 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
10d slower than avg
Panel avg: 107d · This submission: 117d
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 82
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K024342.
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AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036
K023613 · Alphatek Corp. · Jan 2003
K024342 · RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000
Download PDF FDA Summary Daito Co., Ltd.