Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System

K-Number: K232835 · 2024-04-02

ApplicantCanon Medical Systems Corporation
Decision Date2024-04-02
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2024-04-02 under approval number K232835. 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-308A/3) V1.4 with PIQE Reconstruction System?

Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System is a medical device that received FDA 510(k) clearance on 2024-04-02. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K232835.

When was Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System approved by the FDA?

Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System received FDA 510(k) clearance on 2024-04-02, under approval number K232835.

What company makes Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System?

Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System?

The FDA product code for Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System is JAK.

Related Clinical Trials

NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT04289480 Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial Aneurysms ACTIVE_NOT_RECRUITING NCT06385379 Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study) RECRUITING NCT06878768 Translational Research GRICS-CineCardiac COMPLETED NCT06638138 Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability COMPLETED NCT05975359 Assessment of the Interi Manifold in Implant-Based Breast Reconstruction RECRUITING

Other Devices by Canon Medical Systems Corporation

K182601Vitrea Software Package, VSTP-001A K183013Vitrea Software Package, VSTP-001A K181646Celesteion, PCA-9000A/3, V6.5 K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1

View all 96 devices →

Related Devices (Code: JAK)

K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. K163213Revolution CTGe Medical Systems, LLC K161157Vitrea CT Dual Energy Image ViewVital Images, Inc. K160723OnSight 3D Extremity SystemCarestream Health, Inc. K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.

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.

↑