FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EZFluence
K Number: K171352
·
Decision Dec 1, 2017
Classifications
1
FEI Numbers
123
Registration Numbers
124
Same Product Code
717
Applicant Total
10
Review Days
206
Basic Information
- Device Name
- EZFluence
- K Number
- K171352
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radformation, Inc.
- Date Received
- May 9, 2017
- Decision Date
- December 1, 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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