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510(k) K211191

Virtual C DRF Digital Imaging System by Portavision Medical, LLC — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2021
Date Received
April 21, 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

Other clearances by Portavision Medical, LLC

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  • K191503 — MobileRay Pulse SE Digital Imaging System (September 4, 2019)
  • K133524 — PVMED DDR 2430T (April 16, 2014)
  • K083048 — NEORAY DR 2520 DIGITAL IMAGING SYSTEM (November 21, 2008)
  • K072766 — PVMED DDR 2520 DIGITAL IMAGING SYSTEM (December 11, 2007)

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