Home › NIRAMAI HEALTH ANALYTIX PRIVATE LIMITED › BreastHealth-100
BreastHealth-100
NIRAMAI HEALTH ANALYTIX PRIVATE LIMITED · Model v4.13.0 · UDI-DI 08908019450118
LHQ
Prescription
1
510(k) clearances
6
Adverse events (1 deaths)
1
Recalls
13
Facilities
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-01-14 | Med-Hot Thermal Imaging, Inc. | Indications for use are not cleared or approved for market in the U.S. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.