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Data / Medical devices / System, Image Processing, Radiological / Italy

FDA-registered makers of System, Image Processing, Radiological in Italy: 13 establishments

13 establishments in Italy are registered with the FDA to make System, Image Processing, Radiological (product code LLZ). 12 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
System, Image Processing, Radiological
Product code
LLZ
Country
Italy

Makers of System, Image Processing, Radiological in Italy

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
De Gotzen S.R.L.FAGNANO OLONA Varese, ItalyExporter to the US, Manufacturer2February 11, 2020000api.fda.gov
3diemme SRLCantu Como, ItalyManufacturer1December 20, 2018000api.fda.gov
Cefla S.C.IMOLA Bologna, ItalyManufacturer1May 4, 2026000api.fda.gov
EBIT S.r.l.Genova, ItalyManufacturer1June 23, 2017000api.fda.gov
Esaote S.P.A.GENOVA Liguria, ItalyManufacturer1September 19, 2012000api.fda.gov
Media Lab S.P.A.Follo La Spezia, ItalyManufacturer1February 25, 2016000api.fda.gov
Medimatic S.R.L.Genova, ItalyComplaint file establishment, Manufacturer1June 22, 2004000api.fda.gov
Neologica S.R.L.CAIRO MONTENOTTE Savona, ItalyManufacturer1August 1, 2014000api.fda.gov
Orthofix SRLBUSSOLENGO Verona, ItalyManufacturer1October 27, 2020000api.fda.gov
Videomed SRLPordenone, ItalyComplaint file establishment, Manufacturer1May 27, 2026000api.fda.gov
Videomed SRLLIMENA Padova, ItalySpecification developer1May 27, 2026000api.fda.gov
Zirkonzahn SRLGais Bolzano, ItalyManufacturer1July 20, 2021000api.fda.gov
Nical SPAMILAN (MI) Lombardy, ItalyManufacturer0000api.fda.gov

Updated November 2, 2026. 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.