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FDA 510(k)

Virtual C DRF-NEO Digital Imaging System

K-Number: K212557 · 2021-09-24

ApplicantPortavision Medical, LLC
Decision Date2021-09-24
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Virtual C DRF-NEO Digital Imaging System is a medical device manufactured by Portavision Medical, LLC. It received FDA 510(k) clearance on 2021-09-24 under approval number K212557. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Virtual C DRF-NEO Digital Imaging System?

Virtual C DRF-NEO Digital Imaging System is a medical device that received FDA 510(k) clearance on 2021-09-24. It is manufactured by Portavision Medical, LLC. The 510(k) number is K212557.

When was Virtual C DRF-NEO Digital Imaging System approved by the FDA?

Virtual C DRF-NEO Digital Imaging System received FDA 510(k) clearance on 2021-09-24, under approval number K212557.

What company makes Virtual C DRF-NEO Digital Imaging System?

Virtual C DRF-NEO Digital Imaging System is manufactured by Portavision Medical, LLC.

What is the FDA product code for Virtual C DRF-NEO Digital Imaging System?

The FDA product code for Virtual C DRF-NEO Digital Imaging System is OWB.

Related Clinical Trials

NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07612332 Non-Immersive Virtual Reality for Gait and Balance Training in Children With Cerebral Palsy NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41883556 A clinician's quick‑start guide to implementing digital health innovations in the NHS - with lessons from a UK-deployed AI stroke imaging decision-support software. Digital health (2026) PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026)

Other Devices by Portavision Medical, LLC

K191503MobileRay Pulse SE Digital Imaging System K211191Virtual C DRF Digital Imaging System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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