Cleared Traditional

K951373 - FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ

K951373 is an FDA 510(k) clearance for FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, manufactured by Fujifilm Medical System U.S.A., Inc.. The device is a Class 2 Radiology device with product code IXW cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K951373 · Fujifilm Medical System U.S.A., Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
214d
Days
Class 2
Risk

K951373 is an FDA 510(k) clearance for the FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ. Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by Fujifilm Medical System U.S.A., Inc. (Stamford, US). The FDA issued a Cleared decision on October 27, 1995 after a review of 214 days - an extended review 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 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 Fujifilm Medical System U.S.A., Inc. devices

FDA 510(k) Submission Details - K951373

510(k) Number K951373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1995
Decision Date October 27, 1995
Days to Decision 214 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
107d slower than avg
Panel avg: 107d · This submission: 214d
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 50
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K951373.
KODAK MINILOADER(2000)
K970059 · Eastman Kodak Company · Jan 1997
3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR
K962750 · Imation Corp. · Aug 1996
JPI AUTOMATIC X-RAY FILM PROCESSOR
K955706 · Jpi Healthcare Co, Ltd. · Feb 1996
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