Second Opinion

GUDID 00860003567920

Pearl Inc.

Radiology DICOM image processing application software

• Primary Device ID: 00860003567920
• NIH Device Record Key: b2298fa4-0f11-4853-93e8-ad107d47bc09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Second Opinion
• Version Model Number: 2
• Company DUNS: 118187332
• Company Name: Pearl 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	00860003567920 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210365

FDA Product Code

• MYN: Analyzer, Medical Image

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: 2025-01-20
• Device Publish Date: 2025-01-10