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FDA 510(k)

Philips CT 3500

K-Number: K223311 · 2022-12-22

ApplicantPhilips Healthcare (Suzhou) Co., Ltd.
Decision Date2022-12-22
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Philips CT 3500 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2022-12-22 under 510(k) number K223311. 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 CT 3500?

Philips CT 3500 is a medical device that received FDA 510(k) clearance on 2022-12-22. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K223311.

When did Philips CT 3500 receive FDA 510(k) clearance?

Philips CT 3500 received FDA 510(k) clearance on 2022-12-22, under 510(k) number K223311.

Who is the listed applicant for Philips CT 3500?

The FDA 510(k) record lists Philips Healthcare (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips CT 3500?

The FDA product code for Philips CT 3500 is JAK.

Other records listing Philips Healthcare (Suzhou) Co., Ltd. as applicant

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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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