FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RefleXion Medical Radiotherapy System
K Number: K190978
·
Decision Mar 12, 2020
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
3
Review Days
332
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Basic Information
- Device Name
- RefleXion Medical Radiotherapy System
- K Number
- K190978
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Reflexion Medical, Inc.
- Date Received
- April 15, 2019
- Decision Date
- March 12, 2020
- 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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