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FDA 510(k)

OPTIMA CT660

K-Number: K110227 · 2011-07-20

ApplicantGe Medical Systems, LLC
Decision Date2011-07-20
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPTIMA CT660 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 2011-07-20 under 510(k) number K110227. 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 CT660?

OPTIMA CT660 is a medical device that received FDA 510(k) clearance on 2011-07-20. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K110227.

When did OPTIMA CT660 receive FDA 510(k) clearance?

OPTIMA CT660 received FDA 510(k) clearance on 2011-07-20, under 510(k) number K110227.

Who is the listed applicant for OPTIMA CT660?

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 OPTIMA CT660?

The FDA product code for OPTIMA CT660 is JAK.

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Other records listing Ge Medical Systems, LLC as applicant

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Related Devices (Code: JAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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