D-SPECT ® processing and Reviewing Workstation 8010113-01

GUDID 07290108670080

Single Photon Emission Computed Tomography system, stand alone processing station.

SPECTRUM DYNAMICS MEDICAL, INC

SPECT system workstation
Primary Device ID07290108670080
NIH Device Record Key44d02b05-fa55-410b-a5ab-dce96c50d918
Commercial Distribution StatusIn Commercial Distribution
Brand NameD-SPECT ® processing and Reviewing Workstation
Version Model NumberStand Alone
Catalog Number8010113-01
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
GS107290108670080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

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 Date2017-10-25

Devices Manufactured by SPECTRUM DYNAMICS MEDICAL, INC

07290108670172 - VERITON CT2023-06-09 Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging.
07290108670189 - VERITON CT2023-06-09 Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging.
07290108670202 - VERITON NM2023-06-09 Single Photon Emission Computed Tomography System WITH ‘TOTAL BODY’ ACQUISITION
07290108670219 - VERITON CT2023-06-09 Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging.
07290108670226 - VERITON CT2023-06-09 Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging.
07290108670240 - VERITON NM2023-06-09 Single Photon Emission Computed Tomography System WITH ‘TOTAL BODY’ ACQUISITION
07290108670158 - D-SPECT Refurbished2020-12-21 Single Photon Emission Computed Tomography system
07290108670141 - D-SPECT VISTA2020-10-01 Single Photon Emission Computed Tomography System, 230V

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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