Neuviz 16 Multi-Slice Ct Scanner System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K090173

Identifiers

510(k) Number: K090173 FDA 510(k)
FDA Product Code: JAK FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 892.1750 FDA 510(k)
Regulation Number: 892.1750 FDA 510(k)
Advisory Committee: Radiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

At Neusoft Medical Systems Co., Ltd., we are committed to providing high-quality, innovative medical devices that exceed customer expectations. Our NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM is a robust and reliable system designed for comprehensive diagnostic imaging, offering unparalleled image quality and accuracy in various fields such as oncology, cardiovascular, and musculoskeletal imaging. With its advanced features and user-friendly interface, this device has become an industry standard in the medical community.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K090173	Class II	Active

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Manufacturer

Manufacturer: Neusoft Medical Systems Co., Ltd.

Sources (1)

FDA 510(k) K090173 24 fields · synced Jul 6, 2026