iQuest

GUDID 00850012642008

AI SaMD for prostate cancer.

Avenda Health, Inc.

MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software

• Primary Device ID: 00850012642008
• NIH Device Record Key: e6690d45-b73a-4cdf-bd9e-9f844c6075ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iQuest
• Version Model Number: V0.1.4
• Company DUNS: 102268407
• Company Name: Avenda Health, 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	00850012642008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221624

FDA Product Code

• POK: Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

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: 2023-02-23
• Device Publish Date: 2023-02-15

Devices Manufactured by Avenda Health, Inc.

• 00850012642022 - Unfold AI: 2023-12-26 The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct
• 00850012642015 - Unfold AI: 2023-03-30 The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct
• 00850012642008 - iQuest: 2023-02-23AI SaMD for prostate cancer.
• 00850012642008 - iQuest: 2023-02-23 AI SaMD for prostate cancer.