FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Insight Enhanced DRF Digital Imaging System
K Number: K200396
·
Decision Mar 6, 2020
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
4
Review Days
17
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Basic Information
- Device Name
- Insight Enhanced DRF Digital Imaging System
- K Number
- K200396
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imaging Engineering, LLC
- Date Received
- February 18, 2020
- Decision Date
- March 6, 2020
- 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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