510(k) K252954

Device

MammoSightAI

Applicant

Neurocareai, Inc. (Dba Savelife.Ai)

510(k) number

K252954

Product code

QFM

Decision

Substantially Equivalent (SESE)

Decision date

2026-05-04

Date received

2025-09-16

Regulation

892.2080

Classification name

Radiological Computer-Assisted Prioritization Software For Lesions

Medical specialty

Radiology

Review panel

Radiology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N