Cleared Traditional

K961768 - KODAK DIGITAL SCIENCE FILM DIGITIZER L7...

K961768 is an FDA 510(k) clearance for KODAK DIGITAL SCIENCE FILM DIGITIZER L7..., manufactured by Kodak Health Imaging Systems, Inc.. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K961768 · Kodak Health Imaging Systems, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Aug 1996
Decision
106d
Days
Class 2
Risk

K961768 is an FDA 510(k) clearance for the KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER). Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Kodak Health Imaging Systems, Inc. (Dallas, US). The FDA issued a Cleared decision on August 22, 1996 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2030 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kodak Health Imaging Systems, Inc. devices

FDA 510(k) Submission Details - K961768

510(k) Number K961768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1996
Decision Date August 22, 1996
Days to Decision 106 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
1d faster than avg
Panel avg: 107d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LMA Device Classification - Class 2, Special Controls

Product Code LMA Digitizer, Image, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2030
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 - LMA Digitizer, Image, Radiological

Devices cleared under the same product code (LMA) and FDA review panel - the closest regulatory comparables to K961768.
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