Devices · Siemens Medical Solution USA, Inc.

Biograph Horizon

510(k)K193178RadiologyKPS

Siemens Medical Solution USA, Inc. is listed for Biograph Horizon (K193178). The FDA list gives February 12, 2020 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is KPS. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193178

Official FDA database record

Date of final decision: February 12, 2020
Company on the FDA list: Siemens Medical Solution USA, Inc.
Lead panel: Radiology
Primary product code: KPS
openFDA device name for the code: System, Tomography, Computed, Emission
Device class: 2
Regulation number: 892.1200
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary