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D-Spect® L

FDA UDI

Class II (US FDA UDI)

by Spectrum Dynamics Medical Inc.

Identity

Trade Name
D-SPECT® L FDA UDI
Generic Name
SPECT system, annular detector array FDA UDI
Device Name
Single-photon emission computed tomography system FDA UDI
Model / Reference
001 FDA UDI
Description
Single-photon emission computed tomography system FDA UDI

Identifiers

Catalog Number
8010020-01 FDA UDI
Primary DI / UDI-DI
07290108670042 FDA UDI
FDA Product Code
KPS FDA UDI
LLZ FDA UDI
GMDN Term
SPECT system, annular detector array FDA UDI

Classification

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

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: SPECT system, annular detector array

D-Spect® L by Spectrum Dynamics Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as SPECT system, annular detector array.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spectrum Dynamics Medical Inc.

Sources (1)

  • FDA UDI 1070dd42-8685-48ab-9657-4f8a3be98afb 34 fields · synced May 29, 2026