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uWS

FDA UDI

Class II (US FDA UDI)

by Shanghai United Imaging Healthcare Co., Ltd.

Identity

Trade Name
uWS FDA UDI
Generic Name
MRI system application software FDA UDI
Device Name
MR Image Post-processing Software FDA UDI
Model / Reference
uWS-MR FDA UDI
Description
MR Image Post-processing Software FDA UDI

Identifiers

Primary DI / UDI-DI
06971576834143 FDA UDI
510(k) Number
K192601 FDA UDI
K220332 FDA UDI
FDA Product Code
LLZ FDA UDI
QIH FDA UDI
GMDN Term
MRI system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
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

Yes

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

Category: MRI system application software

uWS by Shanghai United Imaging Healthcare Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as MRI system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shanghai United Imaging Healthcare Co., Ltd.

Sources (1)

  • FDA UDI f932e533-96b8-4e08-9c30-301d6dc40183 35 fields · synced Jun 8, 2026