Cleared Traditional

K980722 - TRIMAX RADIOGRAPHIC CASSETTE

K980722 is an FDA 510(k) clearance for TRIMAX RADIOGRAPHIC CASSETTE, manufactured by Imation Corp.. The device is a Class 2 Radiology device with product code IXA cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K980722 · Imation Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
27d
Days
Class 2
Risk

K980722 is an FDA 510(k) clearance for the TRIMAX RADIOGRAPHIC CASSETTE. Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by Imation Corp. (Oakdale, US). The FDA issued a Cleared decision on March 23, 1998 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1850 - 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.

FDA 510(k) Submission Details - K980722

510(k) Number K980722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1998
Decision Date March 23, 1998
Days to Decision 27 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
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXA Device Classification - Class 2, Special Controls

Product Code IXA Cassette, Radiographic Film
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1850
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 - IXA Cassette, Radiographic Film

All 49
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K980722.
LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE
K013229 · Ferrania USA, Inc. · Oct 2001
LIFERAY WL CASSETTE, LIFERAY KW CASSETTE
K012373 · Ferrania S.P.A. · Aug 2001
RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)
K983918 · Mastek, Inc. · Mar 1999
CM & CM DS-7
K963914 · Konica Medical Corp. · Oct 1997
UMI X-RAY FILM CASSETTE
K971431 · Umi Intl. · May 1997
SOLO-SLED
K970090 · Solo-Sled, LLC · Apr 1997
K980722 · TRIMAX RADIOGRAPHIC CASSETTE
Download PDF FDA Summary Imation Corp.