SMILE-100 System NA

GUDID 08908019450057

The SMILE-100 System is a breast thermography device with a visualization tool that helps a healthcare personnel to review, measure and analyze thermally significant indications in the breast region. It is intended to be used in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or an environment where patient care is provided by qualified healthcare personnel.

NIRAMAI HEALTH ANALYTIX PRIVATE LIMITED

Infrared thermography interpretive software

• Primary Device ID: 08908019450057
• NIH Device Record Key: 3c08e0cf-7677-40f2-ab01-c7034e633728
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMILE-100 System
• Version Model Number: v4.8.0
• Catalog Number: NA
• Company DUNS: 860371138
• Company Name: NIRAMAI HEALTH ANALYTIX 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: 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	08908019450057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212965

FDA Product Code

• LHQ: System, Telethermographic (Adjunctive Use)

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: 2025-02-26
• Device Publish Date: 2025-02-18