Cleared Traditional

K971894 - KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM

K971894 is an FDA 510(k) clearance for KODAK DIGITAL SCIENCE - DENTAL SCANNING..., manufactured by Eastman Kodak Company. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K971894 · Eastman Kodak Company · Radiology device
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Aug 1997
Decision
90d
Days
Class 2
Risk

K971894 is an FDA 510(k) clearance for the KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on August 20, 1997 after a review of 90 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 Eastman Kodak Company devices

FDA 510(k) Submission Details - K971894

510(k) Number K971894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1997
Decision Date August 20, 1997
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
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 30
Devices cleared under the same product code (LMA) and FDA review panel - the closest regulatory comparables to K971894.
DI-2000
K980213 · Lumisys, Inc. · Mar 1998
SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM
K974619 · Afp Imaging Corp. · Feb 1998
DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)
K973411 · General Scanning, Inc. · Dec 1997
HOWTEK 960
K970908 · Howtek, Inc. · May 1997
CALL-RAD PC TELERADIOLOGY
K964288 · Pc Teleradiology · Apr 1997
FILM SCANNER 300
K960839 · Cannon U.S.A., Inc. · Dec 1996