Ezra Flash

GUDID 00086001026461

Ezra Ai, Inc.

Radiology DICOM image processing application software

• Primary Device ID: 00086001026461
• NIH Device Record Key: 6e2b3097-b49d-4162-b293-e3b11b43761d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ezra Flash
• Version Model Number: FLHAI00PL01IF00IT00LB01
• Company DUNS: 117008148
• Company Name: Ezra Ai, 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	00086001026461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230264

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: 2024-12-31
• Device Publish Date: 2024-12-23

On-Brand Devices [Ezra Flash]

• 00086001026461: FLHAI00PL01IF00IT00LB01
• 00860010264614: FLHAI00PL01IF00IT00LB01