FDA 510(k)

OPTIMA CT520

K-Number: K123596 · 2013-02-08

ApplicantGe Hangwei Medical Systems Co., Ltd.

Decision Date2013-02-08

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OPTIMA CT520 is the device name listed in this FDA 510(k) record. The listed applicant is Ge Hangwei Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2013-02-08 under 510(k) number K123596. 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 OPTIMA CT520?

OPTIMA CT520 is a medical device that received FDA 510(k) clearance on 2013-02-08. The listed applicant is Ge Hangwei Medical Systems Co., Ltd.. The 510(k) number is K123596.

When did OPTIMA CT520 receive FDA 510(k) clearance?

OPTIMA CT520 received FDA 510(k) clearance on 2013-02-08, under 510(k) number K123596.

Who is the listed applicant for OPTIMA CT520?

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

What is the FDA product code for OPTIMA CT520?

The FDA product code for OPTIMA CT520 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.