FDA 510(k)

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

K-Number: K103365 · 2011-01-12

ApplicantGe Healthcare Coils (Usa Instruments, Inc.)

Decision Date2011-01-12

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). It received FDA 510(k) clearance on 2011-01-12 under 510(k) number K103365. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A?

DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A is a medical device that received FDA 510(k) clearance on 2011-01-12. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). The 510(k) number is K103365.

When did DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A receive FDA 510(k) clearance?

DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A received FDA 510(k) clearance on 2011-01-12, under 510(k) number K103365.

Who is the listed applicant for DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A?

The FDA 510(k) record lists Ge Healthcare Coils (Usa Instruments, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A?

The FDA product code for DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A is MOS.

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Related Devices (Code: MOS)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.