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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Analogic Corporation. It received FDA 510(k) clearance on 2021-02-02 under 510(k) 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. The listed applicant is Analogic Corporation. The 510(k) number is K201231.

When did CTxx85 CT Scanner receive FDA 510(k) clearance?

CTxx85 CT Scanner received FDA 510(k) clearance on 2021-02-02, under 510(k) number K201231.

Who is the listed applicant for CTxx85 CT Scanner?

The FDA 510(k) record lists Analogic Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CTxx85 CT Scanner?

The FDA product code for CTxx85 CT Scanner is JAK.

Other records listing Analogic Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182147CTXX85K172058CT6485, CT12885K161342Sonic Window

Related Devices (Code: JAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLCK253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationK253649Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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