Standard Imaging RAy Software 91336

GUDID 00866562000274

Standard Imaging RAy Software is a film dosimetry application, designed to perform one-dimensional, two-dimensional, and three-dimensional analyses of dose deposition pattern on film under specific mega-voltage irradiation setups.

STANDARD IMAGING INC.

Radiation therapy software

• Primary Device ID: 00866562000274
• NIH Device Record Key: 8a4278b5-e0f1-4fc1-9554-d56b060f2d4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard Imaging RAy Software
• Version Model Number: 91336
• Catalog Number: 91336
• Company DUNS: 788084705
• Company Name: STANDARD IMAGING INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Manufacturing Date: false
• 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	00866562000274 [Primary]

FDA Product Code

• MWW: Accessory - Film Dosimetry System

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: 2023-06-30
• Device Publish Date: 2023-06-22

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