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FDA 510(k)

MSK EXTREME MR SCANNER, MODEL AA5000

K-Number: K080048 · 2008-02-06

ApplicantOni Medical Systems, Inc.
Decision Date2008-02-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MSK EXTREME MR SCANNER, MODEL AA5000 is the device name listed in this FDA 510(k) record. The listed applicant is Oni Medical Systems, Inc.. It received FDA 510(k) clearance on 2008-02-06 under 510(k) number K080048. 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 MSK EXTREME MR SCANNER, MODEL AA5000?

MSK EXTREME MR SCANNER, MODEL AA5000 is a medical device that received FDA 510(k) clearance on 2008-02-06. The listed applicant is Oni Medical Systems, Inc.. The 510(k) number is K080048.

When did MSK EXTREME MR SCANNER, MODEL AA5000 receive FDA 510(k) clearance?

MSK EXTREME MR SCANNER, MODEL AA5000 received FDA 510(k) clearance on 2008-02-06, under 510(k) number K080048.

Who is the listed applicant for MSK EXTREME MR SCANNER, MODEL AA5000?

The FDA 510(k) record lists Oni Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MSK EXTREME MR SCANNER, MODEL AA5000?

The FDA product code for MSK EXTREME MR SCANNER, MODEL AA5000 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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