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)
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.

View all Daito Co., Ltd. devices

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
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 51
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K024342.
XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT
K111167 · Velopex International, Inc. · Aug 2011
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