Cleared Traditional

K960839 - FILM SCANNER 300

K960839 is an FDA 510(k) clearance for FILM SCANNER 300, manufactured by Cannon U.S.A., Inc.. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K960839 · Cannon U.S.A., Inc. · Radiology device
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Dec 1996
Decision
296d
Days
Class 2
Risk

K960839 is an FDA 510(k) clearance for the FILM SCANNER 300. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Cannon U.S.A., Inc. (Lake Success, US). The FDA issued a Cleared decision on December 18, 1996 after a review of 296 days - an extended review cycle.

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 Cannon U.S.A., Inc. devices

FDA 510(k) Submission Details - K960839

510(k) Number K960839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1996
Decision Date December 18, 1996
Days to Decision 296 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
189d slower than avg
Panel avg: 107d · This submission: 296d
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

All 25
Devices cleared under the same product code (LMA) and FDA review panel - the closest regulatory comparables to K960839.
KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM
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HOWTEK 960
K970908 · Howtek, Inc. · May 1997
CALL-RAD PC TELERADIOLOGY
K964288 · Pc Teleradiology · Apr 1997
KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER)
K961768 · Kodak Health Imaging Systems, Inc. · Aug 1996
SCANMASTER DX
K953117 · Howtek, Inc. · Jan 1996
ASPECT ACQUISITION MODULE (AAM)
K954875 · Aspect Electronics, Inc. · Jan 1996