DaTQUANT

GUDID 00195278011343

G E MEDICAL SYSTEMS ISRAEL LTD.

SPECT system application software

• Primary Device ID: 00195278011343
• NIH Device Record Key: 09e4baed-2256-47cc-8618-42402008c8d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DaTQUANT
• Version Model Number: 2.0
• Company DUNS: 532102365
• Company Name: G E MEDICAL SYSTEMS ISRAEL LTD.
• 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: true
• Serial Number: false
• 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	00195278011343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130884

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: 2
• Public Version Date: 2026-01-30
• Device Publish Date: 2020-06-16

On-Brand Devices [DaTQUANT]

• 00840682119306: 1.0
• 00195278011343: 2.0