FDA.reportPublic FDA data

BreastHealth-100

Primary DI
08908019450118
Brand
BreastHealth-100
Company
NIRAMAI HEALTH ANALYTIX PRIVATE LIMITED
Model
v4.13.0
Catalog number
NA
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.
Published
2025-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LHQSystem, Telethermographic (Adjunctive Use)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHQSystem, Telethermographic (Adjunctive Use)Obstetrics/Gynecology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212965000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212965000Smile-100 SystemNiramai Health Analytix Private Limited2022-03-10LHQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08908019450118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908019450118089080194501188908019450118

Regulatory Flags#

DUNS number
860371138
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08908019450057SMILE-100 Systemv4.8.0NA2025-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B783706400170601189MedithermMeditherm IncorporatedLHQ2026-05-18
B783706400170601185MedithermMeditherm IncorporatedLHQ2026-05-01
B783706400170601158MedithermMeditherm IncorporatedLHQ2026-03-31
B783706400170601159MedithermMeditherm IncorporatedLHQ2026-03-23
B783706400170601152MedithermMeditherm IncorporatedLHQ2026-03-18
B783706400170601154MedithermMeditherm IncorporatedLHQ2026-03-18
00860008801906ThermPixUSA THERM, INC.LHQ2026-01-27
B783706400170601148MedithermMeditherm IncorporatedLHQ2025-12-22
B783706400170601149MedithermMeditherm IncorporatedLHQ2025-12-22
B783706400170601151MedithermMeditherm IncorporatedLHQ2025-07-30
B783706400170601141MedithermMeditherm IncorporatedLHQ2025-07-23
B783706400170601142MedithermMeditherm IncorporatedLHQ2025-07-23
B783706400170601145MedithermMeditherm IncorporatedLHQ2025-07-23
B783706400170601146MedithermMeditherm IncorporatedLHQ2025-07-23
B783706400170601147MedithermMeditherm IncorporatedLHQ2025-07-23
B783706400170601132MedithermMeditherm IncorporatedLHQ2025-07-02
B783706400170601144MedithermMeditherm IncorporatedLHQ2025-07-02
B783706400170601140MedithermMeditherm IncorporatedLHQ2025-05-08
B783706400170601143MedithermMeditherm IncorporatedLHQ2025-05-08
06429810718037ThermidasTherMidas OyLHQ2025-04-08
06429810718044ThermidasTherMidas OyLHQ2025-04-08
B783706400170601133MedithermMeditherm IncorporatedLHQ2025-02-24
B783706400170601136MedithermMeditherm IncorporatedLHQ2025-02-24
B783706400170601137MedithermMeditherm IncorporatedLHQ2025-02-24
08908019450057SMILE-100 SystemNIRAMAI HEALTH ANALYTIX PRIVATE LIMITEDLHQ2025-02-18
B783706400170601138MedithermMeditherm IncorporatedLHQ2024-10-25
B783706400170601135MedithermMeditherm IncorporatedLHQ2024-09-09
10853818007504USB C AdapterPRECISION BIOMETRICS INCLHQ2024-09-03
00853818007491USB A to C CablePRECISION BIOMETRICS INCLHQ2024-09-03
00853818007507USB C to C CablePRECISION BIOMETRICS INCLHQ2024-09-03