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FDA 510(k)

IQon Spectral CT

K-Number: K193454 · 2020-01-24

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2020-01-24
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IQon Spectral CT 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 2020-01-24 under 510(k) number K193454. 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 IQon Spectral CT?

IQon Spectral CT is a medical device that received FDA 510(k) clearance on 2020-01-24. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K193454.

When did IQon Spectral CT receive FDA 510(k) clearance?

IQon Spectral CT received FDA 510(k) clearance on 2020-01-24, under 510(k) number K193454.

Who is the listed applicant for IQon Spectral CT?

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 IQon Spectral CT?

The FDA product code for IQon Spectral CT 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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