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 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981280 · Bayer Corp., Agfa Div. · Radiology device
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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

Submission Details

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.

Device Classification

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.