Access CT
K-Number: K191136 · 2019-07-29
Decision Date2019-07-29
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Access CT is a medical device manufactured by Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2019-07-29 under approval number K191136. 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 Access CT?
Access CT is a medical device that received FDA 510(k) clearance on 2019-07-29. It is manufactured by Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K191136.
When was Access CT approved by the FDA?
Access CT received FDA 510(k) clearance on 2019-07-29, under approval number K191136.
What company makes Access CT?
Access CT is manufactured by Philips Healthcare (Suzhou) Co., Ltd..
What is the FDA product code for Access CT?
The FDA product code for Access CT is JAK.
Other Devices by Philips Healthcare (Suzhou) Co., Ltd.
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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.