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 ID: 07290108670080
• NIH Device Record Key: 44d02b05-fa55-410b-a5ab-dce96c50d918
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-SPECT ® processing and Reviewing Workstation
• Version Model Number: Stand Alone
• Catalog Number: 8010113-01
• Company DUNS: 078864620
• Company Name: SPECTRUM DYNAMICS MEDICAL, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290108670080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160120

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-25

Devices Manufactured by SPECTRUM DYNAMICS MEDICAL, INC

• 07290108670172 - VERITON CT: 2023-06-09 Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging.
• 07290108670189 - VERITON CT: 2023-06-09 Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging.
• 07290108670202 - VERITON NM: 2023-06-09 Single Photon Emission Computed Tomography System WITH ‘TOTAL BODY’ ACQUISITION
• 07290108670219 - VERITON CT: 2023-06-09 Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging.
• 07290108670226 - VERITON CT: 2023-06-09 Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging.
• 07290108670240 - VERITON NM: 2023-06-09 Single Photon Emission Computed Tomography System WITH ‘TOTAL BODY’ ACQUISITION
• 07290108670158 - D-SPECT Refurbished: 2020-12-21 Single Photon Emission Computed Tomography system
• 07290108670141 - D-SPECT VISTA: 2020-10-01 Single Photon Emission Computed Tomography System, 230V