FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
BEAMSCAN
K Number: K161807
·
Decision May 19, 2017
Classifications
1
FEI Numbers
123
Registration Numbers
124
Same Product Code
717
Applicant Total
1
Review Days
322
Basic Information
- Device Name
- BEAMSCAN
- K Number
- K161807
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PTW-Freiburg Physikalisch Technische-Werksraetten
- Date Received
- July 1, 2016
- Decision Date
- May 19, 2017
- Product Code
- IYE
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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