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syngo X Workplace

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare

Identity

Trade Name
syngo X Workplace FDA UDI
Generic Name
Diagnostic x-ray digital imaging system workstation FDA UDI
Model / Reference
10281299 FDA UDI

Identifiers

Primary DI / UDI-DI
04056869010120 FDA UDI
510(k) Number
K042995 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Diagnostic x-ray digital imaging system workstation 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

No

FDA UDI

Category: Diagnostic x-ray digital imaging system workstation

syngo X Workplace by Siemens Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic x-ray digital imaging system workstation.

Cleared under the same submission

K042995 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare

Sources (1)

  • FDA UDI f71ab9b3-5840-465e-9ff4-a6a9e2b7481b 35 fields · synced May 30, 2026