510(k) K212557
K212557 is an FDA 510(k) premarket notification submitted by Portavision Medical, LLC for the device "Virtual C DRF-NEO Digital Imaging System". The FDA issued a decision of Substantially Equivalent on September 24, 2021. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Portavision Medical, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 2021
- Date Received
- August 13, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Interventional Fluoroscopic X-Ray System
- Device Class
- Class II
- Regulation Number
- 892.1650
- Review Panel
- RA
- Submission Type
Interventional fluoroscopy