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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 a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2021-03-24 under approval 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. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K203225.

When was Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System approved by the FDA?

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

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

Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System is manufactured by Canon Medical Systems Corporation.

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.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT02710916 SD-OCT Multimodal Analysis in GLaucoma COMPLETED NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT07608614 Sleep and Performance RECRUITING NCT06861309 Placental Imaging Techniques RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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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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