Cleared Abbreviated

K002640 - FREEDOM AUTOMATIC FILM PROCESSOR

K002640 is an FDA 510(k) clearance for FREEDOM AUTOMATIC FILM PROCESSOR, manufactured by J. Morita USA, Inc.. The device is a Class 2 Radiology device with product code IXW cleared through the Abbreviated 510(k) pathway after a 76-day FDA review.

K002640 · J. Morita USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
76d
Days
Class 2
Risk

K002640 is an FDA 510(k) clearance for the FREEDOM AUTOMATIC FILM PROCESSOR. Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on November 8, 2000 after a review of 76 days - a notably fast clearance cycle.

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.

View all J. Morita USA, Inc. devices

FDA 510(k) Submission Details - K002640

510(k) Number K002640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2000
Decision Date November 08, 2000
Days to Decision 76 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
31d faster than avg
Panel avg: 107d · This submission: 76d
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 42
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K002640.
KODAK MINILOADER(2000)
K970059 · Eastman Kodak Company · Jan 1997
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ
K951373 · Fujifilm Medical System U.S.A., Inc. · Oct 1995
KODAK AUTOMIXER II PLUS
K954484 · Eastman Kodak Company · Oct 1995
KODAK X-OMAT 3000 RA PROCESSOR
K951396 · Eastman Kodak Company · May 1995
KODAK X-OMAT 5000 RA PROCESSOR
K951397 · Eastman Kodak Company · May 1995
FUJI COMPUTED RADIOGRAPHY SYSTEMS
K944046 · Fujifilm Medical System U.S.A., Inc. · May 1995