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-305A/3) V7.3

K-Number: K160587 · 2016-06-09

ApplicantToshibamedical Systems Corporation
Decision Date2016-06-09
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aquilion ONE (TSX-305A/3) V7.3 is a medical device manufactured by Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2016-06-09 under approval number K160587. 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-305A/3) V7.3?

Aquilion ONE (TSX-305A/3) V7.3 is a medical device that received FDA 510(k) clearance on 2016-06-09. It is manufactured by Toshibamedical Systems Corporation. The 510(k) number is K160587.

When was Aquilion ONE (TSX-305A/3) V7.3 approved by the FDA?

Aquilion ONE (TSX-305A/3) V7.3 received FDA 510(k) clearance on 2016-06-09, under approval number K160587.

What company makes Aquilion ONE (TSX-305A/3) V7.3?

Aquilion ONE (TSX-305A/3) V7.3 is manufactured by Toshibamedical Systems Corporation.

What is the FDA product code for Aquilion ONE (TSX-305A/3) V7.3?

The FDA product code for Aquilion ONE (TSX-305A/3) V7.3 is JAK.

Other Devices by Toshibamedical Systems Corporation

K162183Vantage Galan 3T, MRT-3020, V4.0 K162155Xario 200 Diagnostic Ultrasound System V5.0 K162614Infinix, INFX-8000V, V6.35 K162187Xario 100 Diagnostic Ultrasound System, V5.0 K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 K160632Vantage Titan 1.5T, MRT-1510, V3.6 Software

View all 27 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.

↑