Biograph Horizon— 510(k) K193178
Substantially EquivalentSiemens Medical Solution USA, Inc.
FDA 510(k) clearance K193178 for Biograph Horizon, Substantially Equivalent on 2020-02-12. Applicant: Siemens Medical Solution USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solution 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
- Traditional
- Location
- Knoxville, TN, US
Recent devices under product code KPS
view allMore clearances from Siemens Medical Solution USA, Inc.
view allRecalls naming K193178
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193178.
Data sourced from openFDA. This site is unofficial and independent of the FDA.