GE Discovery Nm/CT 570C

• • Terminated Z-2196-2017 FDA Class II ·initiated 19 May 2017

  It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

510(k) Number

K083504 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Ge Medical Systems F.I. Haifa →