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FDA 510(k)

MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A

K-Number: K082485 · 2008-09-09

ApplicantNeusoft Medical Systems Co., Ltd.
Decision Date2008-09-09
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A 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 2008-09-09 under 510(k) number K082485. 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 MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A?

MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A is a medical device that received FDA 510(k) clearance on 2008-09-09. The listed applicant is Neusoft Medical Systems Co., Ltd.. The 510(k) number is K082485.

When did MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A receive FDA 510(k) clearance?

MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A received FDA 510(k) clearance on 2008-09-09, under 510(k) number K082485.

Who is the listed applicant for MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A?

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 MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A?

The FDA product code for MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A 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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