Standard Imaging PIPSpro Software 91309

GUDID 00866562000236

Standard Imaging PIPSpro Software is a stand alone software medical device used for QA checks of imaging systems used with radiation therapy systems.

STANDARD IMAGING INC.

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• Primary Device ID: 00866562000236
• NIH Device Record Key: 186d9f3b-ac9e-4f27-a9e2-131c5d4c8a32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard Imaging PIPSpro Software
• Version Model Number: v5
• Catalog Number: 91309
• 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: 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	00866562000236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042733

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-11

Devices Manufactured by STANDARD IMAGING INC.

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