Cleared Traditional

K972847 - KODAK DIGITAL SCIENCE 9000D MEDICAL LAS...

K972847 is the FDA 510(k) clearance for KODAK DIGITAL SCIENCE 9000D MEDICAL LAS... by Eastman Kodak Company. It is a Class 2 Radiology device (product code LMC) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K972847 · Eastman Kodak Company · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
67d
Days
Class 2
Risk

K972847 is an FDA 510(k) clearance for the KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D). Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on October 7, 1997 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2040 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Eastman Kodak Company devices

Submission Details

510(k) Number K972847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1997
Decision Date October 07, 1997
Days to Decision 67 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
40d faster than avg
Panel avg: 107d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LMC Camera, Multi Format, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2040
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 - LMC Camera, Multi Format, Radiological

All 33
Devices cleared under the same product code (LMC) and FDA review panel - the closest regulatory comparables to K972847.
FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L
K033377 · Fujifilm Medical System U.S.A., Inc. · Jan 2004
KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY
K002146 · Eastman Kodak Company · Sep 2000
KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600
K983905 · Eastman Kodak Company · Jan 1999
FUJI MEDICAL DRY IMAGER FM-DP 2636
K962967 · Fujifilm Medical System U.S.A., Inc. · Oct 1996
SIENET TELERADIOLOGY PRODUCT LINE
K955394 · Siemens Medical Solutions USA, Inc. · Feb 1996
FUJI MEDICAL LASER IMAGERMULTI-FORMATTERS MF-300 AND MF-300L
K950721 · Fujifilm Medical System U.S.A., Inc. · May 1995