FDA UDI
In Commercial Distribution
🇺🇸 United States
BreastHealth-100
DI: 08908019450118
·
Model: v4.13.0
·
NIRAMAI HEALTH ANALYTIX PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BreastHealth-100
- Primary DI
- 08908019450118
- Version / Model
- v4.13.0
- Catalog Number
- NA
- Company Name
- NIRAMAI HEALTH ANALYTIX PRIVATE LIMITED
- Labeler DUNS
- 860371138
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-21
- Public Version
- 1
- Public Version Date
- 2025-12-01
- Public Version Status
- New
- Public Device Record Key
- e6315395-f9fc-4f97-ae52-eed454510e78
Device Description
BreastHealth-100 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
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LHQ | System, Telethermographic (Adjunctive Use) | Obstetrics/Gynecology | 884.2980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08908019450118 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212965 | 000 |