FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
SYNGO.CT CORONARY ANALYSIS
K Number: K100637
·
Decision May 26, 2010
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
31
Review Days
82
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Basic Information
- Device Name
- SYNGO.CT CORONARY ANALYSIS
- K Number
- K100637
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens AG Medical Solutions
- Date Received
- March 5, 2010
- Decision Date
- May 26, 2010
- 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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