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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 X3 + Bone/Xact + ACSC FDA UDI
Model / Reference
4.38.3.3 FDA UDI
Description
WBR Imaging X3 + Bone/Xact + ACSC FDA UDI

Identifiers

Primary DI / UDI-DI
00850040177114 FDA UDI
510(k) Number
K030870 FDA UDI
K031874 FDA UDI
K040370 FDA UDI
K081201 FDA UDI
K091073 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: SPECT system application software

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

Similar devices

Also classified as SPECT system application software.

Cleared under the same submission

K030870 also covers:

K031874 also covers:

K040370 also covers:

K081201 also covers:

K091073 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ultraspect Usa, Llc

Sources (1)

  • FDA UDI 37430033-56c6-4d6b-a2f0-36ebc1c594e6 34 fields · synced May 30, 2026