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FDA 510(k)

SUPERSTAR 0.35T MRI SYSTEM

K-Number: K071154 · 2007-05-10

ApplicantNeusoft Medical Systems Co., Ltd.
Decision Date2007-05-10
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SUPERSTAR 0.35T MRI SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Neusoft Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2007-05-10 under 510(k) number K071154. 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 SUPERSTAR 0.35T MRI SYSTEM?

SUPERSTAR 0.35T MRI SYSTEM is a medical device that received FDA 510(k) clearance on 2007-05-10. The listed applicant is Neusoft Medical Systems Co., Ltd.. The 510(k) number is K071154.

When did SUPERSTAR 0.35T MRI SYSTEM receive FDA 510(k) clearance?

SUPERSTAR 0.35T MRI SYSTEM received FDA 510(k) clearance on 2007-05-10, under 510(k) number K071154.

Who is the listed applicant for SUPERSTAR 0.35T MRI SYSTEM?

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

What is the FDA product code for SUPERSTAR 0.35T MRI SYSTEM?

The FDA product code for SUPERSTAR 0.35T MRI SYSTEM is LNH.

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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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