D-SPECT® Cardio 8010120-01

GUDID 07290108670066

Single Photon Emission Computed Tomography system, 110V

SPECTRUM DYNAMICS MEDICAL, INC

SPECT system, annular detector array
Primary Device ID07290108670066
NIH Device Record Keyc861a587-36ae-4089-bf11-6702fb5f2d0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameD-SPECT® Cardio
Version Model Number004
Catalog Number8010120-01
Company DUNS078864620
Company NameSPECTRUM DYNAMICS MEDICAL, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290108670066 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPSSystem, Tomography, Computed, Emission

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-10-22

On-Brand Devices [D-SPECT® Cardio]

07290108670073Single Photon Emission Computed Tomography system, 230V
07290108670066Single Photon Emission Computed Tomography system, 110V

Trademark Results [D-SPECT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
D-SPECT
D-SPECT
88158203 5762732 Live/Registered
Spectrum Dynamics Medical Limited
2018-10-17
D-SPECT
D-SPECT
77386675 3694626 Live/Registered
SPECTRUM DYNAMICS MEDICAL LIMITED
2008-02-01
D-SPECT
D-SPECT
77275690 not registered Dead/Abandoned
Spectrum Dynamics LLC
2007-09-10

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