Cleared Traditional

K981280 - CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS

K981280 is an FDA 510(k) clearance for CP 1000, manufactured by Bayer Corp., Agfa Div.. The device is a Class 2 Radiology device with product code IXW cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K981280 · Bayer Corp., Agfa Div. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
22d
Days
Class 2
Risk

K981280 is an FDA 510(k) clearance for the CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY .... Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by Bayer Corp., Agfa Div. (Ridgefield Park, US). The FDA issued a Cleared decision on April 30, 1998 after a review of 22 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bayer Corp., Agfa Div. devices

FDA 510(k) Submission Details - K981280

510(k) Number K981280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1998
Decision Date April 30, 1998
Days to Decision 22 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
85d faster than avg
Panel avg: 107d · This submission: 22d
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 44
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K981280.
FREEDOM AUTOMATIC FILM PROCESSOR
K002640 · J. Morita USA, Inc. · Nov 2000
MAMMOLOADER BY C.M.A. SRL
K973125 · C.M.A. · Oct 1997
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