ImagingRing

GUDID 19120075320037

medPhoton GmbH

Computed radiography digital imaging scanner Computed radiography digital imaging scanner

• Primary Device ID: 19120075320037
• NIH Device Record Key: 652f57a8-d0b0-4f22-a7d1-63189226be1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImagingRing
• Version Model Number: 1.2
• Company DUNS: 300376801
• Company Name: medPhoton 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	19120075320037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161400

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-10-25

On-Brand Devices [ImagingRing]

• 19120075320037: 1.2
• 19120075320013: 1.1