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Fischer Pps/Mammotest Mammography System

by Fischer Imaging Corp.

510(k) K861692

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK861692 Date15 Dec 1986ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0379-05 FDA Unclassified (pre-2012) initiated 9 Jul 2004

    X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning.

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  • Withdrawn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
IZH
Device Class
Class II
Regulation
21 CFR Part 892.1710
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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