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Efilm Workstation with Modules

by Efilm Medical, Inc.

510(k) K020995

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 NumberK020995 Date12 Apr 2002ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0707-2017 FDA Class II initiated 20 Oct 2016

    A product issues happens for RF projection images. If user measures on RF image, .cal (Calibration) is not displayed and measurement is not correct. The .cal label is not displayed on the projection images after calibration is performed which should be present if the measurement is presented based on Pixel Spacing.

    • Terminated Z-0068-2015 FDA Class II initiated 28 Aug 2014

    There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and utilizing the thumbnail panel to select multiple series from multiple studies may lead to the selection of an incorrect study.

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  • Withdrawn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
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Efilm Medical, Inc.

  • Efilm Workstation

    Class II

  • Efilm Video

    Class II