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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 the device name listed in this FDA 510(k) record. The listed applicant is Portavision Medical, LLC. It received FDA 510(k) clearance on 2021-09-24 under 510(k) 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. The listed applicant is Portavision Medical, LLC. The 510(k) number is K212557.

When did Virtual C DRF-NEO Digital Imaging System receive FDA 510(k) clearance?

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

Who is the listed applicant for Virtual C DRF-NEO Digital Imaging System?

The FDA 510(k) record lists Portavision Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Portavision Medical, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211191Virtual C DRF Digital Imaging SystemK191503MobileRay Pulse SE Digital Imaging System

Related Devices (Code: OWB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.K252503Intelligent NRCanon, Inc.K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.

Official Source

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

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