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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 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 2017-04-07 under 510(k) 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. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K162838.

When did Philips iCT CT System receive FDA 510(k) clearance?

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

Who is the listed applicant for Philips iCT CT System?

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 iCT CT System?

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

Other records listing Philips Medical Systems (Cleveland), Inc. as applicant

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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