Cleared Traditional

KODAK DIGITAL SCIENCE PRO-MEDICAL THERMAL PRINTER (K971973) - FDA 510(k) Clearance

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

K971973 · Eastman Kodak Company · Radiology device
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Aug 1997
Decision
88d
Days
Class 2
Risk

K971973 is an FDA 510(k) clearance for the KODAK DIGITAL SCIENCE PRO-MEDICAL THERMAL PRINTER. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on August 25, 1997 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Eastman Kodak Company devices

Submission Details

510(k) Number K971973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1997
Decision Date August 25, 1997
Days to Decision 88 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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 LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 749
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K971973.
KODAK DIGITAL SCIENCE ONCOLOGY IMAGE MANAGER
K980118 · Eastman Kodak Company · Mar 1998
KODAK DIGITAL SCIENCE CARDIAC VIEWER
K974086 · Eastman Kodak Company · Jan 1998
REALTIME 3D DIAGNOSTIC WORKSTATION
K973010 · Siemens Medical Solutions USA, Inc. · Nov 1997
EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS
K962010 · Philips Medical Systems (Cleveland), Inc. · Mar 1997
FLOUROSPOT T.O.P.
K961871 · Siemens Medical Solutions USA, Inc. · Jul 1996
ADVANTAGE WINDOWS WITH FUNCTOOL OPTION
K960265 · GE Medical Systems · Jul 1996