syngo.SPECT Processing

FDA UDI

Class II (US FDA UDI)

by Siemens Medical Solutions Usa, Inc.

Identity

Trade Name: syngo.SPECT Processing FDA UDI
Generic Name: PET system application software FDA UDI
Model / Reference: 11431531 FDA UDI

Identifiers

Primary DI / UDI-DI: 04056869243399 FDA UDI
510(k) Number: K191309 FDA UDI
FDA Product Code: LLZ FDA UDI
GMDN Term: PET 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: SPECT system application software PET system application software

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

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Cleared under the same submission

K191309 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 30be2671-4e48-4db7-94bf-da06414e59f1 34 fields · synced Jun 8, 2026