Cleared Special

KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622 (K020635) - FDA 510(k) Clearance

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

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 141
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K020635.
KODAK DIRECTVIEW DR SYSTEM DETECTOR
K051483 · Eastman Kodak Company · Jun 2005
PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM
K024147 · Varian Medical Systems, Inc. · Feb 2003
MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM
K021829 · Eastman Kodak Company · Jul 2002
THORAX FD AND MULTIX FD
K983732 · Siemens Medical Solutions USA, Inc. · Apr 1999