FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
syngo.CT Cardiac Planning
K Number: K170221
·
Decision Apr 21, 2017
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
31
Review Days
86
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Basic Information
- Device Name
- syngo.CT Cardiac Planning
- K Number
- K170221
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare GmbH
- Date Received
- January 25, 2017
- Decision Date
- April 21, 2017
- Product Code
- JAK
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
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