FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GammaPod - Model A
K Number: K172706
·
Decision Dec 22, 2017
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
47
Applicant Total
2
Review Days
106
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Basic Information
- Device Name
- GammaPod - Model A
- K Number
- K172706
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xcision Medical Systems, LLC
- Date Received
- September 7, 2017
- Decision Date
- December 22, 2017
- Product Code
- IWB
- 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 |
|---|---|---|---|
| IWB | System, Radiation Therapy, Radionuclide | FDA class 2 | Radiology |
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Other Clearances by Xcision Medical Systems, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K180571 | GammaPod | Apr 4, 2018 | Substantially Equivalent |