ANDI

GUDID 00754016387111

Imeka Solutions Inc

Radiology PACS software

• Primary Device ID: 00754016387111
• NIH Device Record Key: f220b438-2a4a-41f4-aad6-e0c6ec53ec40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANDI
• Version Model Number: 1
• Company DUNS: 203306964
• Company Name: Imeka Solutions 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00754016387111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230913

FDA Product Code

• QIH: Automated Radiological Image Processing Software

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: 2023-09-11
• Device Publish Date: 2023-09-01