FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GammaPod
K Number: K180571
·
Decision Apr 4, 2018
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
47
Applicant Total
2
Review Days
30
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- GammaPod
- K Number
- K180571
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xcision Medical Systems, LLC
- Date Received
- March 5, 2018
- Decision Date
- April 4, 2018
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IWB), ordered by most recent decision date.
Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion)
FDA 510(k)
FDA Class 2
·Radiology
Leksell GammaPlan (LGP)
FDA 510(k)
FDA Class 2
·Radiology
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
FDA 510(k)
FDA Class 2
·Radiology
TaiChiC
FDA 510(k)
FDA Class 2
·Radiology
Akesis Galaxy RTi
FDA 510(k)
FDA Class 2
·Radiology
Akesis Galaxy RTx
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Xcision Medical Systems, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K172706 | GammaPod - Model A | Dec 22, 2017 | Substantially Equivalent |