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FDA 510(k)

Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System

K-Number: K203225 · 2021-03-24

ApplicantCanon Medical Systems Corporation
Decision Date2021-03-24
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System 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 2021-03-24 under 510(k) number K203225. 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 (TSX-306A/3) V10.4 with Spectral Imaging System?

Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System is a medical device that received FDA 510(k) clearance on 2021-03-24. The listed applicant is Canon Medical Systems Corporation. The 510(k) number is K203225.

When did Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System receive FDA 510(k) clearance?

Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System received FDA 510(k) clearance on 2021-03-24, under 510(k) number K203225.

Who is the listed applicant for Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System?

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 ONE (TSX-306A/3) V10.4 with Spectral Imaging System?

The FDA product code for Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System 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.

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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.

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