Augmento

GUDID 08908023670007

DEEPTEK MEDICAL IMAGING PRIVATE LIMITED

Radiology DICOM image processing application software

• Primary Device ID: 08908023670007
• NIH Device Record Key: cd32ed0d-f0b9-454c-b247-b15b2497b13b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Augmento
• Version Model Number: 2.2.65
• Company DUNS: 861402871
• Company Name: DEEPTEK MEDICAL IMAGING PRIVATE LIMITED
• 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: 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	08908023670007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222781

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2025-05-02
• Device Publish Date: 2025-04-24

Devices Manufactured by DEEPTEK MEDICAL IMAGING PRIVATE LIMITED

• 08908023670007 - Augmento: 2025-05-02
• 08908023670007 - Augmento: 2025-05-02
• 08908023670038 - DeepTek CXR Analyzer: 2025-05-02