Cleared Special

K021829 - MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM

K021829 is an FDA 510(k) clearance for MODIFICATION TO KODAK DIRECTVIEW CR 800..., 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 28-day FDA review.

K021829 · Eastman Kodak Company · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
28d
Days
Class 2
Risk

K021829 is an FDA 510(k) clearance for the MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM. 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 July 2, 2002 after a review of 28 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.

FDA 510(k) Submission Details - K021829

510(k) Number K021829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2002
Decision Date July 02, 2002
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
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 423
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K021829.
DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS
K023586 · Canon USA, Inc. · Nov 2002
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
SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW
K013897 · Bio-Scan S.A · May 2002
KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622
K020635 · Eastman Kodak Company · Mar 2002
KONICA DIRECT DIGITIZER REGIUS MODEL 350
K013054 · Konica Minolta Medical & Graphic, Inc. · Mar 2002
K021829 · MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM
Download PDF FDA Summary Eastman Kodak Company