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FDA 510(k)

Philips Incisive CT

K-Number: K212441 · 2022-04-27

ApplicantPhilips Healthcare (Suzhou) Co., Ltd.
Decision Date2022-04-27
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Philips Incisive CT 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 2022-04-27 under 510(k) number K212441. 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 Incisive CT?

Philips Incisive CT is a medical device that received FDA 510(k) clearance on 2022-04-27. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K212441.

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

Philips Incisive CT received FDA 510(k) clearance on 2022-04-27, under 510(k) number K212441.

Who is the listed applicant for Philips Incisive CT?

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 Incisive CT?

The FDA product code for Philips Incisive CT 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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