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FDA 510(k)

Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A

K-Number: K182223 · 2018-09-14

ApplicantCanon Medical Systems, USA
Decision Date2018-09-14
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A is the device name listed in this FDA 510(k) record. The listed applicant is Canon Medical Systems, USA. It received FDA 510(k) clearance on 2018-09-14 under 510(k) number K182223. 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 Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A?

Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A is a medical device that received FDA 510(k) clearance on 2018-09-14. The listed applicant is Canon Medical Systems, USA. The 510(k) number is K182223.

When did Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A receive FDA 510(k) clearance?

Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A received FDA 510(k) clearance on 2018-09-14, under 510(k) number K182223.

Who is the listed applicant for Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A?

The FDA 510(k) record lists Canon Medical Systems, USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A?

The FDA product code for Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A is JAK.

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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