Biograph Horizon PET/CT— 510(k) K170904
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K170904 for Biograph Horizon PET/CT, Substantially Equivalent on 2017-06-01. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Knoxville, TN, US
Recent devices under product code KPS
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allRecalls naming K170904
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.
- Z-0177-2019 — Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT 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.
- Z-1930-2018 — Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
- Z-1597-2018 — Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170904.
Data sourced from openFDA. This site is unofficial and independent of the FDA.