Biograph Horizon PET/CT— 510(k) K152880

Name: FDA 510(k) clearance K152880
Creator: U.S. Food and Drug Administration
Published: 2016-01-12

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K152880 for Biograph Horizon PET/CT, Substantially Equivalent on 2016-01-12. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.

Clearance details

Applicant: Siemens Medical Solutions USA, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2015-09-30
Decision date: 2016-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Knoxville, TN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K152880

K-number listed on FDA's recall record

Z-0707-2019 — Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.Class II·Terminated·Siemens Medical Solutions USA, Inc.·20181130

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152880.

Data sourced from openFDA. This site is unofficial and independent of the FDA.

Clearance details

Recent devices under product code KPS

More clearances from Siemens Medical Solutions USA, Inc.

Recalls naming K152880