inforMED
OXOClass II

Image-intensified Fluoroscopic X-ray System, Mobile

Radiology · 21 CFR 892.1650

Fluoroscopy of the human body.

MDR events10,986All time
Recalls49All time
Registered firms269Currently listed
510(k) clearances82All time

Product problems

Reported product problem codes, most common first

Device Operates Differently Than Expected3,479
Electrical /Electronic Property Problem1,838
Application Program Freezes or Fails to Launch1,769
Device Displays Incorrect Message1,172
Communication or Transmission Problem1,093
Device Inoperable1,085
Computer Software Problem508
Poor Quality Image408

Trend for “Device Operates Differently Than Expected

No history to chart.

Recalls

49 recall events for this product code

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