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E.cam Computer

by Siemens Medical Solutions USA, Inc.

510(k) K992731

E.cam Computer is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K992731 on 10 Nov 1999, active as of 22 Oct 2026. One FDA recall is linked to it.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK992731 Date10 Nov 1999ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-0914-2015 FDA Class II initiated 8 Apr 2014

    There is a potential for patient finger injury on the e.cam systems.

Timeline

2 dated events

  1. Cleared FDA 510(k) K992731
  2. Recall initiated FDA recalls Z-0914-2015

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  • Withdrawn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
KPS
Device class
Class II
Regulation
21 CFR Part 892.1200
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code KPS (System, Tomography, Computed, Emission).

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