Cleared Traditional

K103365 - DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR) (FDA 510(k) Clearance)

Also includes:

DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR) DISCOVERY 3T 32 CH BODY A

K103365 · Ge Healthcare Coils (Usa Instruments, Inc.) · Radiology device

Jan 2011

Decision

56d

Days

Class 2

Risk

K103365 is an FDA 510(k) clearance for the DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR). This device is classified as a Coil, Magnetic Resonance, Specialty (Class II - Special Controls, product code MOS).

Submitted by Ge Healthcare Coils (Usa Instruments, Inc.) (Aurora, US). The FDA issued a Cleared decision on January 12, 2011, 56 days after receiving the submission on November 17, 2010.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number	K103365 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 17, 2010
Decision Date	January 12, 2011
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF