D-SPECT® 8010018-01

GUDID 07290108670035

Single-photon emission computed tomography system

SPECTRUM DYNAMICS MEDICAL, INC

SPECT system, annular detector array

• Primary Device ID: 07290108670035
• NIH Device Record Key: 4e3e1425-5722-46c1-a385-dae6cb8d53a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-SPECT®
• Version Model Number: 004
• Catalog Number: 8010018-01
• 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	07290108670035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110507

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: 2016-09-22

On-Brand Devices [D-SPECT®]

• 07290108670035: Single-photon emission computed tomography system
• 07290108670028: Single-photon emission computed tomography system
• 07290108670011: Single-photon emission computed tomography system
• 07290108670004: Single-photon emission computed tomography system