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FDA 510(k)

BEYONDIMAGE WORKSTATION

K-Number: K102435 · 2010-10-15

ApplicantNeusoft Medical Systems Co., Ltd.
Decision Date2010-10-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BEYONDIMAGE WORKSTATION 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 2010-10-15 under 510(k) number K102435. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEYONDIMAGE WORKSTATION?

BEYONDIMAGE WORKSTATION is a medical device that received FDA 510(k) clearance on 2010-10-15. The listed applicant is Neusoft Medical Systems Co., Ltd.. The 510(k) number is K102435.

When did BEYONDIMAGE WORKSTATION receive FDA 510(k) clearance?

BEYONDIMAGE WORKSTATION received FDA 510(k) clearance on 2010-10-15, under 510(k) number K102435.

Who is the listed applicant for BEYONDIMAGE WORKSTATION?

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 BEYONDIMAGE WORKSTATION?

The FDA product code for BEYONDIMAGE WORKSTATION is LLZ.

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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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