FDA 510(k)

ADVANTAGE 4D OPTION

K-Number: K032915 · 2003-10-30

Decision Date2003-10-30

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ADVANTAGE 4D OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2003-10-30 under 510(k) number K032915. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANTAGE 4D OPTION?

ADVANTAGE 4D OPTION is a medical device that received FDA 510(k) clearance on 2003-10-30. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K032915.

When did ADVANTAGE 4D OPTION receive FDA 510(k) clearance?

ADVANTAGE 4D OPTION received FDA 510(k) clearance on 2003-10-30, under 510(k) number K032915.

Who is the listed applicant for ADVANTAGE 4D OPTION?

The FDA 510(k) record lists Ge Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVANTAGE 4D OPTION?

The FDA product code for ADVANTAGE 4D OPTION is JAK.

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Official Source

View on FDA Database →

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