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FDA 510(k)

Philips iCT CT System

K-Number: K162838 · 2017-04-07

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date2017-04-07
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Philips iCT CT System is a medical device manufactured by Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 2017-04-07 under approval number K162838. 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 iCT CT System?

Philips iCT CT System is a medical device that received FDA 510(k) clearance on 2017-04-07. It is manufactured by Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K162838.

When was Philips iCT CT System approved by the FDA?

Philips iCT CT System received FDA 510(k) clearance on 2017-04-07, under approval number K162838.

What company makes Philips iCT CT System?

Philips iCT CT System is manufactured by Philips Medical Systems (Cleveland), Inc..

What is the FDA product code for Philips iCT CT System?

The FDA product code for Philips iCT CT System is JAK.

Related Clinical Trials

NCT05673408 NIBP Validation Study RECRUITING

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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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