Analytical Review Station

• • Terminated Z-1421-05 FDA Unclassified (pre-2012) ·initiated 18 Jul 2005 ·on shared 510(k) K955519

  The potential exists for the AI1000 workstation to mix images from one study with images from another study. Mixed studies could be from the same patient or from different patients. Mixed patient images could compromise patient condition or diagnosis and treatment.

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

510(k) Number

K955519 ↗

FDA Product Code

IZI

Device Class

Class II

Regulation

21 CFR Part 892.1600

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• Color Diskstore

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  FDA 510(k) K922647 Active Cleared 11 Aug 1992

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