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FDA 510(k)

Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4

K-Number: K161009 · 2016-07-22

ApplicantToshibamedical Systems Corporation
Decision Date2016-07-22
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 is a medical device manufactured by Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2016-07-22 under approval number K161009. 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 Vision with FIRST 2.0 (CCRS-001B) V7.4?

Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 is a medical device that received FDA 510(k) clearance on 2016-07-22. It is manufactured by Toshibamedical Systems Corporation. The 510(k) number is K161009.

When was Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 approved by the FDA?

Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 received FDA 510(k) clearance on 2016-07-22, under approval number K161009.

What company makes Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4?

Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 is manufactured by Toshibamedical Systems Corporation.

What is the FDA product code for Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4?

The FDA product code for Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 is JAK.

Related Clinical Trials

NCT06692699 The A.R.R.E.S.T.® Spectacle Film Study ACTIVE_NOT_RECRUITING NCT06577948 The P.A.U.S.E.® Spectacle Study ACTIVE_NOT_RECRUITING NCT07341763 Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment NOT_YET_RECRUITING NCT05563402 "Evaluation of Usability and Safety of the Self-balancing Walking System Atalante in Patients With Multiple Sclerosis" COMPLETED NCT07300579 Vascular Events in Noncardiac Surgery Patients Cohort Evaluation Study 2 NOT_YET_RECRUITING NCT07141979 Effects of tDCS on Cognitive Flexibility and EEG Oscillations in Orthorexia Nervosa RECRUITING

Related PubMed Literature

PMID: 40417352 Regulatory aspects of optogenetic research and therapy for retinitis pigmentosa under EU law. Frontiers in medical technology (2025)

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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.

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