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FDA 510(k)

Philips iCT CT system

K-Number: K250648 · 2025-06-27

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2025-06-27
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 Nederland B.V.. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K250648. 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 2025-06-27. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K250648.

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

Philips iCT CT system received FDA 510(k) clearance on 2025-06-27, under 510(k) number K250648.

Who is the listed applicant for Philips iCT CT system?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. 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.

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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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