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

FDA 510(k)

XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0

K-Number: K181415 · 2018-09-10

ApplicantCanon Medical Systems Corporation
Decision Date2018-09-10
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 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 2018-09-10 under 510(k) number K181415. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0?

XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 is a medical device that received FDA 510(k) clearance on 2018-09-10. The listed applicant is Canon Medical Systems Corporation. The 510(k) number is K181415.

When did XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 receive FDA 510(k) clearance?

XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 received FDA 510(k) clearance on 2018-09-10, under 510(k) number K181415.

Who is the listed applicant for XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0?

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 XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0?

The FDA product code for XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 is OWB.

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

View all 97 devices →

Related Devices (Code: OWB)

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.

K254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.K252503Intelligent NRCanon, Inc.K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, 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.

↑