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FDA 510(k)

NeuViz Prime Multi-slice CT Scanner System

K-Number: K171201 · 2017-09-13

ApplicantNeusoft Medical Systems Co., Ltd.
Decision Date2017-09-13
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NeuViz Prime Multi-slice CT Scanner System is a medical device manufactured by Neusoft Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2017-09-13 under approval number K171201. 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 Prime Multi-slice CT Scanner System?

NeuViz Prime Multi-slice CT Scanner System is a medical device that received FDA 510(k) clearance on 2017-09-13. It is manufactured by Neusoft Medical Systems Co., Ltd.. The 510(k) number is K171201.

When was NeuViz Prime Multi-slice CT Scanner System approved by the FDA?

NeuViz Prime Multi-slice CT Scanner System received FDA 510(k) clearance on 2017-09-13, under approval number K171201.

What company makes NeuViz Prime Multi-slice CT Scanner System?

NeuViz Prime Multi-slice CT Scanner System is manufactured by Neusoft Medical Systems Co., Ltd..

What is the FDA product code for NeuViz Prime Multi-slice CT Scanner System?

The FDA product code for NeuViz Prime Multi-slice CT Scanner System is JAK.

Related Clinical Trials

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

Other Devices by Neusoft Medical Systems Co., Ltd.

K171198NeuViz 16 Essence Multi-slice CT Scanner System K230220NeuViz 128 Multi-Slice CT Scanner System

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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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