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FDA 510(k)

Philips Multislice CT System with Low Dose CT Lung Cancer

K-Number: K153444 · 2016-04-08

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date2016-04-08
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Philips Multislice CT System with Low Dose CT Lung Cancer 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 2016-04-08 under 510(k) number K153444. 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 Philips Multislice CT System with Low Dose CT Lung Cancer?

Philips Multislice CT System with Low Dose CT Lung Cancer is a medical device that received FDA 510(k) clearance on 2016-04-08. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K153444.

When did Philips Multislice CT System with Low Dose CT Lung Cancer receive FDA 510(k) clearance?

Philips Multislice CT System with Low Dose CT Lung Cancer received FDA 510(k) clearance on 2016-04-08, under 510(k) number K153444.

Who is the listed applicant for Philips Multislice CT System with Low Dose CT Lung Cancer?

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 Philips Multislice CT System with Low Dose CT Lung Cancer?

The FDA product code for Philips Multislice CT System with Low Dose CT Lung Cancer is JAK.

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Related Devices (Code: 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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