← Back to catalogue

Neuviz Dual Multi-Slice Ct Scanner System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K062451

by Neusoft Medical Systems Co., Ltd.

Identifiers

510(k) Number
K062451 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)

Neuviz Dual Multi-Slice Ct Scanner System by Neusoft Medical Systems Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Sources (1)

  • FDA 510(k) K062451 24 fields · synced Jun 18, 2026