iQuest

GUDID 00850012642008

AI SaMD for prostate cancer.

Avenda Health, Inc.

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.

• 00850012642091 - Unfold AI: 2025-10-07 The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct
• 00850012642084 - Unfold AI: 2025-04-08 The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct
• 00850012642077 - Unfold AI: 2025-03-25 The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct
• 00850012642060 - Unfold AI: 2025-02-20 The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct
• 00850012642053 - Unfold AI: 2024-11-28 The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct
• 00850012642046 - Unfold AI: 2024-09-26 The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct
• 00850012642039 - Unfold AI: 2024-05-15 The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct
• 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