FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Akesis Galaxy RTx
K Number: K200050
·
Decision Feb 4, 2020
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
47
Applicant Total
3
Review Days
25
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Basic Information
- Device Name
- Akesis Galaxy RTx
- K Number
- K200050
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Akesis, Inc.
- Date Received
- January 10, 2020
- Decision Date
- February 4, 2020
- 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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