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FDA 510(k)

NeuViz 16 Essence Multi-slice CT Scanner System

K-Number: K171198 · 2017-12-07

ApplicantNeusoft Medical Systems Co., Ltd.
Decision Date2017-12-07
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NeuViz 16 Essence Multi-slice 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 2017-12-07 under 510(k) number K171198. 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 16 Essence Multi-slice CT Scanner System?

NeuViz 16 Essence Multi-slice CT Scanner System is a medical device that received FDA 510(k) clearance on 2017-12-07. The listed applicant is Neusoft Medical Systems Co., Ltd.. The 510(k) number is K171198.

When did NeuViz 16 Essence Multi-slice CT Scanner System receive FDA 510(k) clearance?

NeuViz 16 Essence Multi-slice CT Scanner System received FDA 510(k) clearance on 2017-12-07, under 510(k) number K171198.

Who is the listed applicant for NeuViz 16 Essence Multi-slice 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 16 Essence Multi-slice CT Scanner System?

The FDA product code for NeuViz 16 Essence Multi-slice CT Scanner System is JAK.

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 SystemK171201NeuViz Prime Multi-slice CT Scanner System

Related Devices (Code: JAK)

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.

K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLCK253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationK253649Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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