GIOTTO IMAGE 6501M1

GUDID 18056977360080

IMS GIOTTO SPA

Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital

• Primary Device ID: 18056977360080
• NIH Device Record Key: 01c2d02e-74e8-459a-9858-fdbdba02eccc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GIOTTO IMAGE
• Version Model Number: GIOTTO IMAGE M
• Catalog Number: 6501M1
• Company DUNS: 437701793
• Company Name: IMS GIOTTO SPA
• 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	08056977360083 [Primary]
GS1	18056977360080 [Package]; Contains: 08056977360083; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012953

FDA Product Code

• MUE: Full Field Digital, System, X-Ray, Mammographic

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: 2021-03-31
• Device Publish Date: 2021-03-23

On-Brand Devices [GIOTTO IMAGE ]

• 18056977360080: GIOTTO IMAGE M
• 18056977360073: GIOTTO IMAGE 3DL/3MP
• 18056977360066: GIOTTO IMAGE 3DL