Cleared Special

K020635 - KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622

Also marketed or referenced as:
KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 1170976

K020635 is an FDA 510(k) clearance for KODAK DIRECTVIEW CR 800 SYSTEM, manufactured by Eastman Kodak Company. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 22-day FDA review.

K020635 · Eastman Kodak Company · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
22d
Days
Class 2
Risk

K020635 is an FDA 510(k) clearance for the KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on March 21, 2002 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Eastman Kodak Company devices

FDA 510(k) Submission Details - K020635

510(k) Number K020635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2002
Decision Date March 21, 2002
Days to Decision 22 days
Submission Type Special
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
85d faster than avg
Panel avg: 107d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 404
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K020635.
KONICA DIRECT DIGITIZER REGIUS, MODEL 170
K023061 · Konica Minolta Medical & Graphic, Inc. · Oct 2002
CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT
K023124 · Canon, Inc. · Oct 2002
MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM
K021829 · Eastman Kodak Company · Jul 2002
KONICA DIRECT DIGITIZER REGIUS MODEL 350
K013054 · Konica Minolta Medical & Graphic, Inc. · Mar 2002
FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II
K013218 · Fujifilm Medical System U.S.A., Inc. · Dec 2001
ADC PEDIATRIC
K012750 · Agfa Corp. · Nov 2001