GIOTTO IMAGE 3DL 6006-15GM3

GUDID 08033837190035

MAW is a Management & Acquisition Workstation with 21" LCD 2Mpixel monitor, dedicated computer for images acquisition/processing. DVD/CD professional burner.

I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL

Radiology DICOM image processing application software

• Primary Device ID: 08033837190035
• NIH Device Record Key: 9426ebb4-ffe9-4f58-b7fe-4d6507156155
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GIOTTO IMAGE 3DL
• Version Model Number: MAW
• Catalog Number: 6006-15GM3
• Company DUNS: 429113525
• Company Name: I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
• 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 Dimensions

• Width: 1175 Millimeter
• Height: 1920 Millimeter
• Depth: 470 Millimeter
• Width: 1175 Millimeter
• Height: 1920 Millimeter
• Depth: 470 Millimeter
• Width: 1175 Millimeter
• Height: 1920 Millimeter
• Depth: 470 Millimeter
• Width: 1175 Millimeter
• Height: 1920 Millimeter
• Depth: 470 Millimeter
• Width: 1175 Millimeter
• Height: 1920 Millimeter
• Depth: 470 Millimeter
• Width: 1175 Millimeter
• Height: 1920 Millimeter
• Depth: 470 Millimeter
• Width: 1175 Millimeter
• Height: 1920 Millimeter
• Depth: 470 Millimeter
• Width: 1175 Millimeter
• Height: 1920 Millimeter
• Depth: 470 Millimeter
• Width: 1175 Millimeter
• Height: 1920 Millimeter
• Depth: 470 Millimeter
• Width: 1175 Millimeter
• Height: 1920 Millimeter
• Depth: 470 Millimeter
• Width: 1175 Millimeter
• Height: 1920 Millimeter
• Depth: 470 Millimeter
• Width: 1175 Millimeter
• Height: 1920 Millimeter
• Depth: 470 Millimeter
• Width: 1175 Millimeter
• Height: 1920 Millimeter
• Depth: 470 Millimeter
• Width: 1175 Millimeter
• Height: 1920 Millimeter
• Depth: 470 Millimeter
• Width: 1175 Millimeter
• Height: 1920 Millimeter
• Depth: 470 Millimeter
• Width: 1175 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033837190035 [Primary]
GS1	18033837190032 [Package]; Package: X003411 [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111434

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-22