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Neuviz 64 Multi-Slice Ct Scanner System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K121792

by Neusoft Medical Systems Co., Ltd.

Identity

Trade Name
NeuViz 64 Multi-slice CT Scanner System FDA UDI
Generic Name
Full-body CT system FDA UDI
Model / Reference
NeuViz 64 En FDA UDI

Identifiers

Primary DI / UDI-DI
06970167440039 FDA UDI
510(k) Number
K121792 FDA 510(k)FDA UDI
FDA Product Code
JAK FDA 510(k)FDA UDI
GMDN Term
Full-body CT system FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Neuviz 64 Multi-Slice Ct Scanner System by Neusoft Medical Systems Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Neusoft Medical Systems Co., Ltd.

Sources (2)

  • FDA 510(k) K121792 24 fields · synced Jun 19, 2026
  • FDA UDI 8be426cc-25cd-4dbe-ab5e-5e65f7667bc3 33 fields · synced May 26, 2026