Cleared Traditional

K042866 - AMX5 AND AMX5D MOBILE X-RAY SYSTEMS (FDA 510(k) Clearance)

K042866 · Ge Healthcare Technologies · Radiology device

Nov 2004

Decision

15d

Days

Class 2

Risk

K042866 is an FDA 510(k) clearance for the AMX5 AND AMX5D MOBILE X-RAY SYSTEMS. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).

Submitted by Ge Healthcare Technologies (Milwaukee, US). The FDA issued a Cleared decision on November 2, 2004, 15 days after receiving the submission on October 18, 2004.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number	K042866 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 18, 2004
Decision Date	November 02, 2004
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF