Second Opinion 3D

GUDID 00860003567944

Pearl Inc.

Radiology DICOM image processing application software

• Primary Device ID: 00860003567944
• NIH Device Record Key: f5613ac5-e3eb-430f-a42c-15e07f3bd918
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Second Opinion 3D
• Version Model Number: 1.x
• 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	00860003567944 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243989

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: 2025-12-22
• Device Publish Date: 2025-12-12

Devices Manufactured by Pearl Inc.

• 00860003567944 - Second Opinion 3D: 2025-12-22
• 00860003567944 - Second Opinion 3D: 2025-12-22
• 00198715016079 - Second Opinion: 2025-08-08
• 00860003567920 - Second Opinion: 2025-01-20