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Ep-X Biplane

by Fischer Imaging Corp.

510(k) K961207

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

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

Overview

The EP-X BIPLANE is a radiology device that provides high-quality X-ray images for medical diagnosis and treatment. It is designed to be used in conjunction with other imaging modalities, such as CT scans or ultrasound, to provide comprehensive patient care.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK961207 Date20 Aug 1996ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-1524-05 FDA Unclassified (pre-2012) initiated 28 Apr 2005
    • Terminated Z-1525-05 FDA Unclassified (pre-2012) initiated 28 Apr 2005
    • Terminated Z-1526-05 FDA Unclassified (pre-2012) initiated 28 Apr 2005

    Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient.

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  • Withdrawn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
JAA
Device Class
Class II
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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