syngo.MM Oncology

FDA UDI

Class II (US FDA UDI)

by Siemens Medical Solutions Usa, Inc.

Identity

Trade Name: syngo.MM Oncology FDA UDI
Generic Name: SPECT system application software FDA UDI
Model / Reference: 11431557 FDA UDI

Identifiers

Primary DI / UDI-DI: 04056869950143 FDA UDI
510(k) Number: K211459 FDA UDI
FDA Product Code: LLZ FDA UDI
QIH FDA UDI
GMDN Term: SPECT 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: SPECT system application software PET system application software

syngo.MM Oncology by Siemens Medical Solutions Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as PET system application software.

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syngo.MI Neurolog — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
syngo.MI General — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
syngo Scenium SPECT — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
syngo.PET&CT Oncology — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
SW-Key: NMG_SCENIUM_ADV VIA — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II

Cleared under the same submission

K211459 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 Medical Solutions Usa, Inc.

Sources (1)

FDA UDI 2a61eb6c-cc40-479b-b002-82b5f2fb63a2 34 fields · synced Jun 8, 2026