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Mammomat Revelation

by Siemens Medi Cal Solutions, Inc.

510(k) K173408

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK173408 Date21 Mar 2018ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2388-2020 FDA Class II initiated 7 May 2020

    If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy system is being used, the tube arm's manual movement range is decreased from +/-15 deg. to +/- 6 deg. This limitation may lead to difficulties in removing the vacuum biopsy system.

    • Terminated Z-0160-2020 FDA Class II initiated 23 Jul 2019

    An error can occur when performing a biopsy using the InSpect function. The acquisition workstation may become unresponsive to normal user interaction, can only take place in rare cases

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MUE
Device Class
Class II
Regulation
21 CFR Part 892.1715
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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