AccessGUDID - DEVICE: SMILE-100 System (08908019450057)

GUDID

Device Identifier (DI) Information

Brand Name: SMILE-100 System
Version or Model: v4.8.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NA
Company Name: NIRAMAI HEALTH ANALYTIX PRIVATE LIMITED

Primary DI Number: 08908019450057
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 860371138 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65132	Infrared thermography interpretive software	An interpretive software program intended to be used to analyse images of the distribution of body surface temperature (thermography images) to detect suspected abnormalities (e.g., breast lesions), and provide data to assist localization of lesions (e.g., colour mapping, tags). It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHQ	System, Telethermographic (Adjunctive Use)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212965	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3c08e0cf-7677-40f2-ab01-c7034e633728
Public Version Date: February 26, 2025
Public Version Number: 1
DI Record Publish Date: February 18, 2025