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/6) V8.9 with AiCE

K-Number: K183046 · 2019-06-12

ApplicantCanon Medical Systems Corporation
Decision Date2019-06-12
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aquilion ONE (TSX-305A/6) V8.9 with AiCE is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2019-06-12 under approval number K183046. 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/6) V8.9 with AiCE?

Aquilion ONE (TSX-305A/6) V8.9 with AiCE is a medical device that received FDA 510(k) clearance on 2019-06-12. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K183046.

When was Aquilion ONE (TSX-305A/6) V8.9 with AiCE approved by the FDA?

Aquilion ONE (TSX-305A/6) V8.9 with AiCE received FDA 510(k) clearance on 2019-06-12, under approval number K183046.

What company makes Aquilion ONE (TSX-305A/6) V8.9 with AiCE?

Aquilion ONE (TSX-305A/6) V8.9 with AiCE is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Aquilion ONE (TSX-305A/6) V8.9 with AiCE?

The FDA product code for Aquilion ONE (TSX-305A/6) V8.9 with AiCE is JAK.

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.

↑