D-SPECT® L 8010032-01

GUDID 07290108670059

Single-photon emission computed tomography system

SPECTRUM DYNAMICS MEDICAL, INC

SPECT system, annular detector array

• Primary Device ID: 07290108670059
• NIH Device Record Key: 1b64d4aa-eb87-4e51-8b60-522301c6bcce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-SPECT® L
• Version Model Number: 001
• Catalog Number: 8010032-01
• 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	07290108670059 [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® L]

• 07290108670059: Single-photon emission computed tomography system
• 07290108670042: Single-photon emission computed tomography system