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SOMATOM Edge Plus

by Siemens Medical Solutions USA, Inc.

510(k) K173607

SOMATOM Edge Plus is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K173607 on 21 Mar 2018, active as of 22 Oct 2026. 3 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

3 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 NumberK173607 Date21 Mar 2018ClearedStatusActive

Official records

Recalls

3 recalls · FDA

    • Terminated Z-0771-2021 FDA Class II initiated 24 Nov 2020

    System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan

    • Terminated Z-2273-2019 FDA Class II initiated 3 Jul 2019

    Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.

    • Terminated Z-1246-2019 FDA Class II initiated 14 Feb 2019

    Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.

Timeline

4 dated events

  1. Cleared FDA 510(k) K173607
  2. Recall initiated FDA recalls Z-1246-2019
  3. Recall initiated FDA recalls Z-2273-2019
  4. Recall initiated FDA recalls Z-0771-2021

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  • Withdrawn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
JAK
Device class
Class II
Regulation
21 CFR Part 892.1750
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

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

Devices cleared under K173607

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K173607
UDI-DISize and differences
SOMATOM Edge Plus 10267000
Siemens Healthcare GmbH
1026700004056869152684 —On the market

Similar devices

Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).

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