D-SPECT® 8010018-01

GUDID 07290108670028

Single-photon emission computed tomography system

SPECTRUM DYNAMICS MEDICAL, INC

SPECT system, annular detector array SPECT system, annular detector array SPECT system, annular detector array SPECT system, annular detector array SPECT system, annular detector array SPECT system, annular detector array SPECT system, annular detector array SPECT system, annular detector array SPECT system, annular detector array SPECT system, annular detector array SPECT system, annular detector array SPECT system, annular detector array SPECT system, annular detector array SPECT system, annular detector array SPECT system, annular detector array SPECT system, annular detector array

• Primary Device ID: 07290108670028
• NIH Device Record Key: 15f228bb-2722-41e8-a932-8a3926ee1276
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-SPECT®
• Version Model Number: 003
• 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	07290108670028 [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