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FDA 510(k)

R2-MRI ANALYSIS SYSTEM

K-Number: K043271 · 2005-01-21

ApplicantInner Vision Biometrics Pty, Ltd.
Decision Date2005-01-21
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

R2-MRI ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Inner Vision Biometrics Pty, Ltd.. It received FDA 510(k) clearance on 2005-01-21 under 510(k) number K043271. 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 R2-MRI ANALYSIS SYSTEM?

R2-MRI ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 2005-01-21. The listed applicant is Inner Vision Biometrics Pty, Ltd.. The 510(k) number is K043271.

When did R2-MRI ANALYSIS SYSTEM receive FDA 510(k) clearance?

R2-MRI ANALYSIS SYSTEM received FDA 510(k) clearance on 2005-01-21, under 510(k) number K043271.

Who is the listed applicant for R2-MRI ANALYSIS SYSTEM?

The FDA 510(k) record lists Inner Vision Biometrics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R2-MRI ANALYSIS SYSTEM?

The FDA product code for R2-MRI ANALYSIS SYSTEM is LNH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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