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Data / Medical devices / United States / Virtual Radiologic Corporation

Virtual Radiologic Corporation: FDA-registered device maker in Edina, MN, United States, 1 510(k) clearance

Virtual Radiologic Corporation is registered with the FDA (registration 3007795813) in Edina, MN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 18, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3007795813
Address
3600 Minnesota Dr Ste 800, Edina, MN, United States, 55435
Owner or operator
Virtual Radiologic Corporation (10029207)
Roles
Manufacturer
First device listed
January 17, 2025
Registered through
2026
Brand names listed
Mosaic Viewer, vRad Viewer

Devices it lists

DeviceProduct codeClassRoleSource
System, Image Processing, RadiologicalLLZ2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 18, 2024K241879vRad ViewerLLZSubstantially EquivalentVirtual Radiologic Corporationaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
May 9, 202392516Class IIOngoingvRad PACS with MammographyThe error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist.accessdata.fda.gov

Compare with other makers

Updated July 18, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.