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Patient Positioning System

by Forte Automation Systems, Inc. 510(k)

Active United States

510(k) K122413

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK122413 Date13 Sep 2012ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-2537-2018 FDA Class II initiated 5 Sep 2017

    Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.

Specification

510(k)

510(k) Number
FDA Product Code
JAI
Device Class
Class II
Regulation
21 CFR Part 892.5770
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Forte Automation Systems, Inc.