Standard Imaging IMSure 3D 91365

GUDID 00850019946543

Standard Imaging IMSure 3D (IM3D) QA software is intended to be used for radiation dose calculation and radiation treatment plan quality assurance in radiation therapy.

STANDARD IMAGING INC.

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• Primary Device ID: 00850019946543
• NIH Device Record Key: 654ffbfb-c38b-49a5-bf99-2e504979c18d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard Imaging IMSure 3D
• Version Model Number: 91365
• Catalog Number: 91365
• Company DUNS: 788084705
• Company Name: STANDARD IMAGING INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Serial Number: false
• 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	00850019946543 [Primary]

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2023-12-07
• Device Publish Date: 2023-11-29

Devices Manufactured by STANDARD IMAGING INC.

• 00850019946543 - Standard Imaging IMSure 3D: 2023-12-07Standard Imaging IMSure 3D (IM3D) QA software is intended to be used for radiation dose calculation and radiation treatment plan quality assurance in radiation therapy.
• 00850019946543 - Standard Imaging IMSure 3D: 2023-12-07 Standard Imaging IMSure 3D (IM3D) QA software is intended to be used for radiation dose calculation and radiation treatment plan
• 00850019946031 - Standard Imaging Seed Slider: 2023-06-30 Standard Imaging Seed Slider is designed for loading LDR Brachytherapy seeds and spacers into prostate needles.
• 00850019946048 - Standard Imaging Needle Loading Shield: 2023-06-30 Standard Imaging Needle Loading Shield provide a convenient work station for counting and handling seeds and for loading into n
• 00850019946062 - Standard Imaging Needle Cradle: 2023-06-30 Standard Imaging Needle Cradle is designed for storage of loaded LDR prostate implant needles, prior to use in a patient.
• 00850019946079 - Standard Imaging CDX 2000B Electrometer: 2023-06-30 Standard Imaging CDX 2000B Electrometer is a portable electrometer designed to be connected to a radiation detector, (ionization
• 00850019946086 - Standard Imaging MAX 4000 Plus Electrometer: 2023-06-30 Standard Imaging MAX 4000 Plus Electrometer is a portable electrometer designed to be connected to a radiation detector, (ioniza
• 00850019946093 - Standard Imaging SuperMAX Electrometer: 2023-06-30 Standard Imaging SuperMAX Electrometer is a 2-channel electrometer designed to be connected to a radiation detector, (ionization
• 00850019946109 - Standard Imaging MAX SD: 2023-06-30 Standard Imaging MAX SD is a high end optical signal processing electrometer designed for use with Exradin W2 scintillation dete