FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Virtual C DRF-NEO Digital Imaging System
K Number: K212557
·
Decision Sep 24, 2021
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
319
Applicant Total
5
Review Days
42
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Basic Information
- Device Name
- Virtual C DRF-NEO Digital Imaging System
- K Number
- K212557
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Portavision Medical, LLC
- Date Received
- August 13, 2021
- Decision Date
- September 24, 2021
- Product Code
- OWB
- 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 |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | FDA class 2 | Radiology |
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Other Clearances by Portavision Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K211191 | Virtual C DRF Digital Imaging System | Jun 24, 2021 | Substantially Equivalent |
| K191503 | MobileRay Pulse SE Digital Imaging System | Sep 4, 2019 | Substantially Equivalent |
| K133524 | PVMED DDR 2430T | Apr 16, 2014 | Substantially Equivalent |
| K083048 | NEORAY DR 2520 DIGITAL IMAGING SYSTEM | Nov 21, 2008 | Substantially Equivalent |