MiE - Gamma Camera Systems

GUDID 04260484140043

The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients.

MiE medical imaging electronics GmbH

Stationary gamma camera system

• Primary Device ID: 04260484140043
• NIH Device Record Key: f2d25c65-f719-4a93-a99b-ef94b5ded571
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiE - Gamma Camera Systems
• Version Model Number: SYNGULA-SCINTRON
• Company DUNS: 537604915
• Company Name: MiE medical imaging electronics GmbH
• 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

Customer Support Contacts

• Phone: +49419499770
• Email: mie@miegermany.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260484140043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053086

FDA Product Code

• IYX: Camera, Scintillation (Gamma)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-07
• Device Publish Date: 2022-11-29

On-Brand Devices [MiE - Gamma Camera Systems]

• 04260484140074: The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated
• 04260484140043: The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated