syngo.CT Cardiac Planning— 510(k) K200515
Substantially EquivalentSiemens Medical Soultions USA, Inc.
FDA 510(k) clearance K200515 for syngo.CT Cardiac Planning, Substantially Equivalent on 2020-03-25. Applicant: Siemens Medical Soultions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Soultions USA, Inc.
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hoffman Estates, IL, US
Recent devices under product code JAK
view allMore clearances from Siemens Medical Soultions USA, Inc.
view allAdverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.