CTxx85 CT Scanner
K-Number: K201231 · 2021-02-02
ApplicantAnalogic Corporation
Decision Date2021-02-02
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CTxx85 CT Scanner is a medical device manufactured by Analogic Corporation. It received FDA 510(k) clearance on 2021-02-02 under approval number K201231. 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 CTxx85 CT Scanner?
CTxx85 CT Scanner is a medical device that received FDA 510(k) clearance on 2021-02-02. It is manufactured by Analogic Corporation. The 510(k) number is K201231.
When was CTxx85 CT Scanner approved by the FDA?
CTxx85 CT Scanner received FDA 510(k) clearance on 2021-02-02, under approval number K201231.
What company makes CTxx85 CT Scanner?
CTxx85 CT Scanner is manufactured by Analogic Corporation.
What is the FDA product code for CTxx85 CT Scanner?
The FDA product code for CTxx85 CT Scanner 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.