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FDA 510(k)

Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE

K-Number: K182901 · 2019-07-05

ApplicantCanon Medical Systems Corporation
Decision Date2019-07-05
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE is the device name listed in this FDA 510(k) record. The listed applicant is Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2019-07-05 under 510(k) number K182901. 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 Precision (TSX-304A/1 and /2) V8.8 with AiCE?

Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE is a medical device that received FDA 510(k) clearance on 2019-07-05. The listed applicant is Canon Medical Systems Corporation. The 510(k) number is K182901.

When did Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE receive FDA 510(k) clearance?

Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE received FDA 510(k) clearance on 2019-07-05, under 510(k) number K182901.

Who is the listed applicant for Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE?

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

What is the FDA product code for Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE?

The FDA product code for Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE is JAK.

Other records listing Canon Medical Systems 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.

K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0K253625Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRK260078Aquilion ServeSP (TSX-307B) V2.0K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemK251370Cartesion Prime (PCD-1000A/3) V10.21

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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

View on FDA Database →

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

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