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Symbia 6.5

by Siemens Medical Solutions USA, Inc.

510(k) K162337

Symbia 6.5 is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K162337 on 8 Sep 2016, active as of 22 Oct 2026. 4 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 · Special NumberK162337 Date8 Sep 2016ClearedStatusActive

Official records

Recalls

4 recalls · FDA

    • Terminated Z-0372-2019 FDA Class II initiated 5 Oct 2018

    The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be labeled 0.55A.,

  • 2 recalls, same reason

    • Terminated Z-0093-2018 FDA Class II initiated 7 Nov 2017
    • Terminated Z-0094-2018 FDA Class II initiated 7 Nov 2017

    The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantification option is calibrated with phantoms that do not have a volume of 6500ml and/or when residual dose needs to be entered.

    • Terminated Z-0047-2018 FDA Class II initiated 18 Sep 2017

    The torque wrench used to tighten system bolts during installation was found to be out of tolerance

Timeline

5 dated events

  1. Cleared FDA 510(k) K162337
  2. Recall initiated FDA recalls Z-0047-2018
  3. Recall initiated FDA recalls Z-0093-2018
  4. Recall initiated FDA recalls Z-0094-2018
  5. Recall initiated FDA recalls Z-0372-2019

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  • Withdrawn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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

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

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