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FDA 510(k)

NEUVIZ SPIRAL CT SCANNER SYSTEM

K-Number: K072841 · 2007-10-16

ApplicantNeusoft Medical Systems Co., Ltd.
Decision Date2007-10-16
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NEUVIZ SPIRAL CT SCANNER 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 2007-10-16 under 510(k) number K072841. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUVIZ SPIRAL CT SCANNER SYSTEM?

NEUVIZ SPIRAL CT SCANNER SYSTEM is a medical device that received FDA 510(k) clearance on 2007-10-16. The listed applicant is Neusoft Medical Systems Co., Ltd.. The 510(k) number is K072841.

When did NEUVIZ SPIRAL CT SCANNER SYSTEM receive FDA 510(k) clearance?

NEUVIZ SPIRAL CT SCANNER SYSTEM received FDA 510(k) clearance on 2007-10-16, under 510(k) number K072841.

Who is the listed applicant for NEUVIZ SPIRAL CT SCANNER 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 NEUVIZ SPIRAL CT SCANNER SYSTEM?

The FDA product code for NEUVIZ SPIRAL CT SCANNER SYSTEM is JAK.

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Other records listing Neusoft Medical Systems Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230220NeuViz 128 Multi-Slice CT Scanner SystemK171198NeuViz 16 Essence Multi-slice CT Scanner SystemK171201NeuViz Prime Multi-slice CT Scanner SystemK121792NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEMK110077NEUCOLONCAREK102435BEYONDIMAGE WORKSTATION

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Related Devices (Code: JAK)

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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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