FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PowerDR
K Number: K191504
·
Decision Aug 16, 2019
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
3
Review Days
71
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Basic Information
- Device Name
- PowerDR
- K Number
- K191504
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radiology Information Systems, Inc.
- Date Received
- June 6, 2019
- Decision Date
- August 16, 2019
- Product Code
- JAA
- 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 |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
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