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FDA 510(k)

BRILLIANCE DUAL ENERGY OPTION

K-Number: K090462 · 2009-06-23

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date2009-06-23
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BRILLIANCE DUAL ENERGY OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 2009-06-23 under 510(k) number K090462. 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 BRILLIANCE DUAL ENERGY OPTION?

BRILLIANCE DUAL ENERGY OPTION is a medical device that received FDA 510(k) clearance on 2009-06-23. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K090462.

When did BRILLIANCE DUAL ENERGY OPTION receive FDA 510(k) clearance?

BRILLIANCE DUAL ENERGY OPTION received FDA 510(k) clearance on 2009-06-23, under 510(k) number K090462.

Who is the listed applicant for BRILLIANCE DUAL ENERGY OPTION?

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

What is the FDA product code for BRILLIANCE DUAL ENERGY OPTION?

The FDA product code for BRILLIANCE DUAL ENERGY 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.

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