SOMATOM go.Sim

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare

Identity

Trade Name: SOMATOM go.Sim FDA UDI
Generic Name: Full-body CT system FDA UDI
Model / Reference: 11061660 FDA UDI

Identifiers

Primary DI / UDI-DI: 04056869249230 FDA UDI
510(k) Number: K192061 FDA UDI
K211373 FDA UDI
K233650 FDA UDI
K250822 FDA UDI
FDA Product Code: JAK FDA UDI
GMDN Term: Full-body CT system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1750 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Full-body CT system

SOMATOM go.Sim by Siemens Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K192061 also covers:

K211373 also covers:

SOMATOM X.ceed — Siemens Healthcare
SOMATOM go.All — Siemens Healthcare
SOMATOM go.Open Pro — Siemens Healthcare
SOMATOM go.Top — Siemens Healthcare
SOMATOM go.Up — Siemens Healthcare

K233650 also covers:

SOMATOM X.ceed — Siemens Healthcare
SOMATOM go.All — Siemens Healthcare
SOMATOM go.Open Pro — Siemens Healthcare
SOMATOM go.Top — Siemens Healthcare
SOMATOM go.Up — Siemens Healthcare

K250822 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare

Sources (1)

FDA UDI fe48944a-34d7-46da-b2fb-3ee969ae1a7d 35 fields · synced May 30, 2026