IXWClass II

Processor, Radiographic-film, Automatic

Radiology · 21 CFR 892.1900

MDR events45All time

Recalls1All time

Registered firms3Currently listed

510(k) clearances83All time

Recent MDR events

45 adverse event reports on file

Event type breakdown

Malfunction35

Other5

Injury3

Unspecified2

Most-reported manufacturers

X-rite13 Eastman Kodak Co.9 Air Techniques, Inc.3 Eastman Kodak Company3 X Rite3 Air Techniques Inc.2 Kodak2 Agfa-gevaert Healthcare Gmbh1

Recalls

1 recall events for this product code

Fujifilm Medical Systems U.S.A., Inc.
TerminatedUnknown
Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
Reports of failure of the device's power supply.
Z-1599-2016 · View FDA record ↗

Registered firms

3 firms currently registered for this product code

510(k) clearances

83 clearances for this product code