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

FDA-registered makers of System, Image Processing, Radiological in Germany: 35 establishments

35 establishments in Germany are registered with the FDA to make System, Image Processing, Radiological (product code LLZ). 29 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.

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

Makers of System, Image Processing, Radiological in Germany

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Siemens Healthineers AGFORCHHEIM Bavaria, GermanyComplaint file establishment, Exporter to the US, Manufacturer53November 20, 2025000api.fda.gov
Siemens Healthineers AGERLANGEN Bavaria, GermanyComplaint file establishment, Manufacturer16September 9, 2025000api.fda.gov
Brainlab SeMunich Bavaria, GermanyExporter to the US, Manufacturer9October 16, 2025030api.fda.gov
GE Healthcare GmbHMunich Bavaria, GermanyManufacturer, Specification developer4July 2, 2024020api.fda.gov
NDS Surgical Imaging, LLCLudwigsstadt Bavaria, GermanyManufacturer4April 28, 2006000api.fda.gov
Sicat GMBH & Co. KGBONN North Rhine-Westphalia, GermanyManufacturer4December 4, 2019010api.fda.gov
Philips Medical Systems DMC GmbHHamburg, GermanyComplaint file establishment, Specification developer3July 28, 2011000api.fda.gov
TOMTEC Imaging Systems GMBHUNTERSCHLEISSHEIM Bavaria, GermanyManufacturer, Specification developer3August 14, 2020010api.fda.gov
Aycan Digitalsysteme GMBHWUERZBURG Bavaria, GermanyManufacturer2September 12, 2012000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer2August 29, 2011000api.fda.gov
Medcom GMBHDarmstadt Hesse, GermanyManufacturer2July 26, 2017000api.fda.gov
Mevis Medical Solutions AGBremen, GermanyComplaint file establishment, Manufacturer2June 30, 2026000api.fda.gov
Oehm Und Rehbein GMBHROSTOCK Mecklenburg-Western Pomerania, GermanyManufacturer2December 11, 2009000api.fda.gov
Sirona Dental Systems GMBHBENSHEIM Hesse, GermanyExporter to the US, Manufacturer2February 25, 2014000api.fda.gov
Visage Imaging GmbHBerlin, GermanyManufacturer2April 28, 2015000api.fda.gov
mediCAD HECTEC GMBHLandshut Bavaria, GermanyManufacturer2October 31, 2019000api.fda.gov
Airamed GMBHTuebingen Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer1August 25, 2023000api.fda.gov
Carl Zeiss Meditec AG (oberkochen)OBERKOCHEN Baden-Wurttemberg, GermanyManufacturer1December 29, 2021000api.fda.gov
Durr Dental SeBietigheim-Bissingen Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer, Specification developer1November 2, 2021000api.fda.gov
Durr Optronik GmbH & Co. KGGechingen Baden-Wurttemberg, GermanyManufacturer1November 2, 2021000api.fda.gov
Exocad GMBHDarmstadt Hesse, GermanyManufacturer1August 6, 2019010api.fda.gov
Heidelberg Engineering GMBHHEIDELBERG Baden-Wurttemberg, GermanyManufacturer1February 18, 2020000api.fda.gov
IMAGE INFORMATION SYSTEMS EUROPE GmbHROSTOCK Mecklenburg-Western Pomerania, GermanyManufacturer1September 19, 2006000api.fda.gov
Image Instruments GMBHChemnitz Saxony, GermanyManufacturer1January 4, 2023000api.fda.gov
Mint Medical GMBHHeidelberg Baden-Wurttemberg, GermanyManufacturer1April 13, 2015020api.fda.gov
MTT GMBHLueneburg Lower Saxony, GermanyManufacturer1August 16, 2012000api.fda.gov
NEXUS / CHILI GmbHDOSSENHEIM/HEIDELBERG Baden-Wurttemberg, GermanyManufacturer1April 6, 2007000api.fda.gov
Roclub GMBHBerlin, GermanyManufacturer, Specification developer1February 4, 2025000api.fda.gov
Vepro AGPFUNGSTADT Hesse, GermanyManufacturer1November 19, 1997000api.fda.gov
Dental Wings GMBHChemnitz Saxony, GermanyManufacturer, Specification developer0000api.fda.gov
Inter Medical Medizintechnik GMBHLUEBBECKE North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
KLS Martin SE & Co. KGMuhlheim/Donau Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Stryker Leibinger GMBH & Co. KGFREIBURG Baden-Wurttemberg, GermanyManufacturer0000api.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.