Philips Incisive CT
K-Number: K212441 · 2022-04-27
Decision Date2022-04-27
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Philips Incisive CT is a medical device manufactured by Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2022-04-27 under approval 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. It is manufactured by Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K212441.
When was Philips Incisive CT approved by the FDA?
Philips Incisive CT received FDA 510(k) clearance on 2022-04-27, under approval number K212441.
What company makes Philips Incisive CT?
Philips Incisive CT is manufactured by Philips Healthcare (Suzhou) Co., Ltd..
What is the FDA product code for Philips Incisive CT?
The FDA product code for Philips Incisive 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.