Standard Imaging DoseView 3D 92260

GUDID 00866562000205

Standard Imaging DoseView 3D is a medical device intended for performing water phantom based commissioning and QA measurements on radiation therapy systems.

STANDARD IMAGING INC.

Accelerator system quality assurance device

• Primary Device ID: 00866562000205
• NIH Device Record Key: 39dd0e81-38ba-4daf-9c48-d562346c3d7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard Imaging DoseView 3D
• Version Model Number: 92260
• Catalog Number: 92260
• Company DUNS: 788084705
• Company Name: STANDARD IMAGING INC.
• 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	00866562000205 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-11

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