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)

Vantage Orian 1.5T, MRT-1550, V6.0

K-Number: K202767 · 2021-01-15

ApplicantCanon Medical Systems Corporation
Decision Date2021-01-15
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vantage Orian 1.5T, MRT-1550, V6.0 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 2021-01-15 under 510(k) number K202767. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vantage Orian 1.5T, MRT-1550, V6.0?

Vantage Orian 1.5T, MRT-1550, V6.0 is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Canon Medical Systems Corporation. The 510(k) number is K202767.

When did Vantage Orian 1.5T, MRT-1550, V6.0 receive FDA 510(k) clearance?

Vantage Orian 1.5T, MRT-1550, V6.0 received FDA 510(k) clearance on 2021-01-15, under 510(k) number K202767.

Who is the listed applicant for Vantage Orian 1.5T, MRT-1550, V6.0?

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 Vantage Orian 1.5T, MRT-1550, V6.0?

The FDA product code for Vantage Orian 1.5T, MRT-1550, V6.0 is LNH.

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: LNH)

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.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, S.p.A.

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.

↑