UltraSPECT

FDA UDI

Class II (US FDA UDI)

by Ultraspect Usa, Llc

Identity

Trade Name: UltraSPECT FDA UDI
Generic Name: SPECT system application software FDA UDI
Device Name: WBR Imaging X + X3 FDA UDI
Model / Reference: 4.38.3.3 FDA UDI
Description: WBR Imaging X + X3 FDA UDI

Identifiers

Primary DI / UDI-DI: 00850040177022 FDA UDI
510(k) Number: K050815 FDA UDI
K081201 FDA UDI
FDA Product Code: LLZ FDA UDI
KPS FDA UDI
GMDN Term: SPECT system application software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
892.1200 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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: SPECT system application software

UltraSPECT by Ultraspect Usa, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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
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syngo.PET&CT Oncology — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II

Cleared under the same submission

K050815 also covers:

K081201 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: Ultraspect Usa, Llc

Sources (1)

FDA UDI 02d1bfc8-fdbe-421e-aaa0-5f7c1cee8694 34 fields · synced May 31, 2026