Cleared Special

K013686 - KODAK DIRECTVIEW TABLETOP CASSETTE

K013686 is an FDA 510(k) clearance for KODAK DIRECTVIEW TABLETOP CASSETTE, manufactured by Eastman Kodak Company. The device is a Class 2 Radiology device with product code IXA cleared through the Special 510(k) pathway after a 30-day FDA review.

K013686 · Eastman Kodak Company · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
30d
Days
Class 2
Risk

K013686 is an FDA 510(k) clearance for the KODAK DIRECTVIEW TABLETOP CASSETTE. Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on December 7, 2001 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K013686

510(k) Number K013686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2001
Decision Date December 07, 2001
Days to Decision 30 days
Submission Type Special
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
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 50
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K013686.
KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253
K040378 · Eastman Kodak Company · May 2004
AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE
K023020 · Agfa Corp. · Sep 2002
KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE
K021903 · Eastman Kodak Company · Jul 2002
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
K013686 · KODAK DIRECTVIEW TABLETOP CASSETTE
Download PDF FDA Summary Eastman Kodak Company