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HealthMammo

by Zebra Medical Vision, Ltd. 510(k)

Active United States

510(k) K200905

Overview

The HealthMammo is a Radiological Computer-Assisted Prioritization Software For Lesions, classified as a device in the Radiology medical specialty. It is designed to assist in the triage of 2D FFDM screening mammogram cases. The device has been validated in a performance study using a retrospective cohort of anonymized 2D FFDM screening mammograms. The study included cases from the USA, UK, and Israel, with both positive and negative results for breast cancer. The HealthMammo is a computer-assisted software, which is substantially equivalent to other devices in its class.

The HealthMammo is supplied as a software device, with a product code of QFM and a regulation number of 892.2080. It is a Class 2 device, with an FDA 510(k) clearance, indicated by the K number K200905. The device is intended for use in a radiology setting, and its use is supported by a performance study. The HealthMammo is not described as single-use or reusable, and its sterility and MRI safety are not specified. The device is stored and used in accordance with its specifications, and its authorizations include FDA 510(k) clearance.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK200905 Date16 Jul 2020ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
QFM
Device Class
Class II
Regulation
21 CFR Part 892.2080
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Zebra Medical Vision, Ltd.

  • HealthCCS

    Class II

  • HealthICH

    Class II

  • HealthPNX

    Class II

  • HealthCXR

    Class II

  • HealthCCSng

    Class II

  • HealthJOINT

    Class II

See all devices from Zebra Medical Vision, Ltd. →

Questions

  • What is the HealthMammo software used for?

    The HealthMammo software is used to assist in the triage of 2D FFDM screening mammogram cases, helping to prioritize lesions for further review.

  • Is the HealthMammo software cleared for use in the US?

    Yes, the HealthMammo software has received FDA 510(k) clearance, indicated by the K number K200905, allowing it to be used in a radiology setting.

  • What type of device is the HealthMammo?

    The HealthMammo is a Class 2 computer-assisted software device, classified as a Radiological Computer-Assisted Prioritization Software For Lesions.

  • How is the HealthMammo software supplied?

    The HealthMammo software is supplied as a software device, with a product code of QFM and a regulation number of 892.2080.