Axiom Artis U

• • Terminated Z-3009-2011 FDA Unclassified (pre-2012) ·initiated 29 Jun 2011 ·on shared 510(k) K040675

  When the heat unit of the angiography system reaches or exceeds 65%, the cool down time display will appear with an acoustic signal. If users ignore the warning and continue the radiation, the tube may be autoprotected when it reaches its temperature limitation causing the X-Ray to lock until the tube cools down. Following a tube auto-protection, an error message "Door is Open" or "Err 421/240:

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K040675 ↗

FDA Product Code

OWB

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K040577 Active Cleared 22 Mar 2004

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  Class II

  FDA 510(k) K023571 Active Cleared 20 Nov 2002

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  Class II

  FDA 510(k) K042328 Active Cleared 14 Sep 2004

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  Class II

  FDA 510(k) K013522 Active Cleared 7 Nov 2001

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