Cleared Traditional

INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE (K911041) - FDA 510(k) Clearance

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

K911041 · Invotec International, Inc. · Radiology device
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Jun 1991
Decision
88d
Days
Class 2
Risk

K911041 is an FDA 510(k) clearance for the INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE. Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by Invotec International, Inc. (Jacksonville, US). The FDA issued a Cleared decision on June 4, 1991 after a review of 88 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.

View all Invotec International, Inc. devices

Submission Details

510(k) Number K911041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1991
Decision Date June 04, 1991
Days to Decision 88 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 107d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 20
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K911041.
DU PONT MV DARKROOM CASSETTE
K931074 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1993
MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDER
K923334 · Cook, Inc. · Jan 1993
KODAK INSIGHT PORTABLE IMAGING SYSTEM
K921826 · Eastman Kodak Company · Aug 1992
DU PONT MAMMOGRAPHY CASSETTE
K900620 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1990
CRONEX COMPACT MAMMOGRAPHY CASSETTE
K895335 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1990
KODAK X-OMATIC RA CASSETTE
K890750 · Eastman Kodak Company · Mar 1989