Data / Medical devices / System, Digital Image Communications, Radiological

System, Digital Image Communications, Radiological (LMD): 138 FDA-registered makers in 21 countries

Name: FDA-registered makers of System, Digital Image Communications, Radiological
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

138 establishments in 21 countries are registered with the FDA to make System, Digital Image Communications, Radiological (product code LMD, Class 1, 21 CFR 892.2020). 1 of them has a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 142 510(k) clearances under this code, the latest on May 26, 2000, and lists 12 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: LMD
Device class: 1
Regulation: 892.2020
Medical specialty: Radiology

Makers by country

Country	Makers
United States	67
Germany	13
South Korea	12
Taiwan	7
China	6
India	5
Japan	4
United Kingdom	4
France	3
Israel	2
Belgium	2
Sweden	2
Canada	2
Australia	2
Italy	1
Denmark	1
Colombia	1
Switzerland	1
Czechia	1
Netherlands	1
Argentina	1

Makers of System, Digital Image Communications, Radiological

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Aspyra, LLC.	Jacksonville, FL, United States	Manufacturer	1	January 2, 1998	0	api.fda.gov
Acula Technology Corp	Luchu Taoyuan, Taiwan	Manufacturer	0		0	api.fda.gov
Aesculap AG	TUTTLINGEN, DONAU Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Aidoc Medical Ltd.	Tel Aviv-Yafo, Israel	Manufacturer	0		0	api.fda.gov
Aiobio Co., Ltd.	Seongnam-si Gyeonggi, South Korea	Exporter to the US, Manufacturer	0		0	api.fda.gov
AIRS Medical Inc.	Seoul, South Korea	Manufacturer	0		0	api.fda.gov
Allm Inc.	Shibuya Tokyo, Japan	Manufacturer	0		0	api.fda.gov
Altamont Software, Inc.	Pleasanton, CA, United States	Manufacturer	0		0	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	0		0	api.fda.gov
Aspen Imaging Healthcare, Inc	Plano, TX, United States	Manufacturer, Remanufacturer, Repackager or relabeler	0		0	api.fda.gov
Asus	Taipei City, Taiwan	Specification developer	0		0	api.fda.gov
Auo (suzhou) Co., Ltd.	Suzhou Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Avreo, Inc.	N Charleston, SC, United States	Manufacturer	0		0	api.fda.gov
Aycan Digitalsysteme GMBH	WUERZBURG Bavaria, Germany	Manufacturer	0		0	api.fda.gov
Activ Surgical Inc	Boston, MA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Arthrex, Inc.	Ave Maria, FL, United States	Contract manufacturer, Contract sterilizer	0		0	api.fda.gov
Barco N.V.	KORTRIJK West-Vlaanderen, Belgium	Manufacturer	0		0	api.fda.gov
Barco S.R.L.	Saronno Varese, Italy	Manufacturer	0		0	api.fda.gov
Beijing Visual Perception Intelligence Technology Co., Ltd.	Tianjin, China	Manufacturer	0		0	api.fda.gov
Blackford Analysis Ltd	EDINBURGH Midlothian, United Kingdom	Manufacturer	0		0	api.fda.gov
Blue Ortho	Meylan Isere, France	Manufacturer	0		0	api.fda.gov
Brainlab Se	Munich Bavaria, Germany	Manufacturer	0		0	api.fda.gov
Brit Systems	Wallingford, CT, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Barco (Suzhou) Healthcare Technology Co., Ltd.	Suzhou Jiangsu, China	Manufacturer	0		0	api.fda.gov
Canon Medical Informatics, Inc.	Minnetonka, MN, United States	Manufacturer	0		0	api.fda.gov
Cardea Technology, Inc.	Arlington, MA, United States	Specification developer	0		0	api.fda.gov
CARL ZEISS MEDITEC AG (Munich)	Muenchen Bavaria, Germany	Specification developer	0		0	api.fda.gov
Carl Zeiss Meditec AG (oberkochen)	OBERKOCHEN Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Claripi Inc.	Seoul, South Korea	Exporter to the US, Manufacturer	0		0	api.fda.gov
Codonics, Inc.	Middleburg Heights, OH, United States	Complaint file establishment, Manufacturer, Remanufacturer	0		0	api.fda.gov
Computer MD	Fort Lauderdale, FL, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Coretronic Projection (kunshan) Corporation	Kunshan Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Canon Medical Informatics A/S	Valby Hovedstaden, Denmark	Manufacturer	0		0	api.fda.gov
Cerner Corporation	Kansas City, MO, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Daikso Co., Ltd.	Guishan Dist., Taoyuan, Taiwan	Foreign private label distributor, Manufacturer	0		0	api.fda.gov
Deephealth	Somerville, MA, United States	Manufacturer	0		0	api.fda.gov
DICOM Grid (dba Ambra Health)	Raleigh, NC, United States	Manufacturer	0		0	api.fda.gov
Dicomserver, LLC	Kingwood, TX, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Digisonics, Inc.	Raleigh, NC, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Diva Laboratories, Ltd.	New Taipei City, Taipei-District, 235, Taiwan	Manufacturer	0		0	api.fda.gov
DRGEM Corporation (Gimcheon Factory)	Gimcheon-si Gyeongbuk, South Korea	Manufacturer	0		0	api.fda.gov
Durico C&T, Inc.	Sangju-si Gyeongbuk, South Korea	Manufacturer	0		0	api.fda.gov
Dicom Systems Inc.	Danville, CA, United States	Manufacturer	0		0	api.fda.gov
E-Com Technology Co.,ltd.	Beijing, China	Manufacturer	0		0	api.fda.gov
Ebm Technologies, Inc.	Taipei, Taiwan	Manufacturer	0		0	api.fda.gov
Echonous, Inc.	Redmond, WA, United States	Manufacturer	0		0	api.fda.gov
Eizo Corporation	HAKUSAN Ishikawa, Japan	Manufacturer	0		0	api.fda.gov
Enlitic, Inc.	Loveland, CO, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Episurf Operations AB	Stockholm, Sweden	Manufacturer	0		0	api.fda.gov
Eysz - NC	Cary, NC, United States	Manufacturer	0		0	api.fda.gov
Exo Imaging, Inc.	Santa Clara, CA, United States	Manufacturer	0		0	api.fda.gov
Foreseeson Custom Displays, Inc.	Anaheim, CA, United States	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler	0		0	api.fda.gov
Fovia, Inc.	Kentfield, CA, United States	Manufacturer	0		0	api.fda.gov
Fujifilm Sonosite,inc.	Bothell, WA, United States	Manufacturer	0		0	api.fda.gov
Get-Grin Inc	Airmont, NY, United States	Manufacturer	0		0	api.fda.gov
Gyrus Acmi, Inc.	Westborough, MA, United States	Specification developer	0		0	api.fda.gov
Hermes Medical Solutions, AB	Stockholm, Sweden	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Hologic, Inc.	Newark, DE, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Holoray Inc.	Westmount Quebec, Canada	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Icad Inc.	Nashua, NH, United States	Manufacturer	0		0	api.fda.gov
Image Diagnostics, Inc.	Fitchburg, MA, United States	Manufacturer	0		0	api.fda.gov
Imaging Experts And Healthcare Services S.A.S	Cundinamarca Bogota, Colombia	Manufacturer	0		0	api.fda.gov
IMRIS Imaging, Inc.	Chaska, MN, United States	Manufacturer	0		0	api.fda.gov
Incremed AG	Zurich, Switzerland	Manufacturer, Specification developer	0		0	api.fda.gov
Infinitt Healthcare Co., Ltd.	Seoul, South Korea	Manufacturer	0		0	api.fda.gov
Irm Inc.	Seoul, South Korea	Manufacturer	0		0	api.fda.gov
Intelerad USA	Raleigh, NC, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
JLK, Inc.	Gangnam Seoul, South Korea	Manufacturer	0		0	api.fda.gov
Kailo Medical Pty Ltd	Hawthorn Victoria, Australia	Manufacturer	0		0	api.fda.gov
Karl Storz Imaging, Inc.	Goleta, CA, United States	Contract manufacturer	0		0	api.fda.gov
Karl Storz Se & Co KG	TUTTLINGEN Baden-Wurttemberg, Germany	Specification developer	0		0	api.fda.gov
Karl Storz Se & Co. KG	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Koven Technology, Inc.	Saint Louis, MO, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Mark Enterprises	Nashik Maharashtra, India	Manufacturer	0		0	api.fda.gov
Marken Healthtech Limited	NASHIK Maharashtra, India	Manufacturer	0		0	api.fda.gov
MCD Medical Computers Deutschland GmbH	Huellhorst North Rhine-Westphalia, Germany	Contract manufacturer	0		0	api.fda.gov
Mcginley Orthopaedic Innovations, Inc	Casper, WY, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Medical Digital Developers LLC	New Rochelle, NY, United States	Manufacturer	0		0	api.fda.gov
Medidata Solutions, Inc. (formerly Intelemage, LLC)	New York, NY, United States	Specification developer	0		0	api.fda.gov
Medimaging Integrated Solution Inc.	Hsinchu Hsinchu(City), Taiwan	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Medit Corp.	Seoul, South Korea	Manufacturer	0		0	api.fda.gov
Mediview XR	Cleveland, OH, United States	Manufacturer	0		0	api.fda.gov
Medsynaptic Private Ltd.	PUNE Maharashtra, India	Manufacturer	0		0	api.fda.gov
Mevis Medical Solutions AG	Bremen, Germany	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Motilent Ltd	London England, United Kingdom	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Mycardium Ai Ltd	Liverpool, United Kingdom	Complaint file establishment, Manufacturer	0		0	api.fda.gov
MediThinQ Co., Ltd.	Seongnam Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Nanjing Jusha Display Technology Co., Ltd	Nanjing Jiangsu, China	Manufacturer	0		0	api.fda.gov
NDS Surgical Imaging, LLC.	Sarasota, FL, United States	Manufacturer, Specification developer	0		0	api.fda.gov
NDS Surgical Imaging, LLC	Ludwigsstadt Bavaria, Germany	Manufacturer	0		0	api.fda.gov
Neuro-Innovations LLC	Chicago, IL, United States	Specification developer	0		0	api.fda.gov
New Lantern	San Francisco, CA, United States	Manufacturer	0		0	api.fda.gov
Novanta Medical S.R.O.	Prelouc Pardubicky Kraj, Czechia	Manufacturer	0		0	api.fda.gov
Nano-X AI Ltd.	Petah Tikva Central, Israel	Manufacturer	0		0	api.fda.gov
Novanta Medical GmbH	LUDWIGSSTADT Bavaria, Germany	Contract manufacturer	0		0	api.fda.gov
Olea Medical	La Ciotat Bouches-du-Rhone, France	Manufacturer	0		0	api.fda.gov
Olympus Winter & Ibe GMBH	Hamburg, Germany	Complaint file establishment, Exporter to the US, Specification developer	0		0	api.fda.gov
Ondal Medical Systems GMBH	Huenfeld Hesse, Germany	Specification developer	0		0	api.fda.gov
Ondal Medical Systems Of America, Inc.	Sandston, VA, United States	Complaint file establishment, Contract manufacturer	0		0	api.fda.gov
Onepacs, LLC	Machesney Park, IL, United States	Manufacturer	0		0	api.fda.gov
Oraq Ai Inc.	Calgary Alberta, Canada	Manufacturer	0		0	api.fda.gov
Orthoscan, Inc.	Scottsdale, AZ, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Overjet	Boston, MA, United States	Manufacturer	0		0	api.fda.gov
Prism Clinical Imaging, Inc.	Elm Grove, WI, United States	Manufacturer	0		0	api.fda.gov
Philips India Limited - Radiology Informatics, Clinical Informatics, Patient Care Informatics Business Units	Bengaluru Karnataka, India	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Philips Ultrasound LLC	Cambridge, MA, United States	Specification developer	0		0	api.fda.gov
Philips Ultrasound LLC	Bothell, WA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Qure.ai Technologies Private Limited	Mumbai Maharashtra, India	Manufacturer	0		0	api.fda.gov
Radiology Information Systems, Inc.	Dulles, VA, United States	Manufacturer	0		0	api.fda.gov
Samsung Medison Co., Ltd.	HONGCHEON-GUN Gangwon, South Korea	Manufacturer	0		0	api.fda.gov
Santa Barbara Imaging Systems	Goleta, CA, United States	Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Scimage, Inc.	Los Altos, CA, United States	Manufacturer	0		0	api.fda.gov
Screenpoint Medical	Nijmegen Gelderland, Netherlands	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Sentiar, Inc.	Saint Louis, MO, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Siemens Medical Solutions Usa, Inc.	Issaquah, WA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Sirona Medical, Inc.	San Francisco, CA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Sonio	Paris, France	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Standard Imaging, Inc.	Middleton, WI, United States	Manufacturer	0		0	api.fda.gov
Stryker Endoscopy	San Jose, CA, United States	Manufacturer	0		1	api.fda.gov
Sydney Neuroimaging Analysis Centre Pty Ltd	Camperdown New South Wales, Australia	Manufacturer	0		0	api.fda.gov
Skytron, LLC	Grand Rapids, MI, United States	Complaint file establishment, Specification developer	0		2	api.fda.gov
SolVIS INC.	Louisville, TN, United States	Manufacturer	0		0	api.fda.gov
Sony Corporation	Yokohama-shi Kanagawa, Japan	Complaint file establishment, Specification developer	0		0	api.fda.gov
Sony Global Manufacturing & Operations Corporation Kohda Site	Nukata-gun Aichi, Japan	Contract manufacturer	0		0	api.fda.gov
Thinking Systems Corp.	Saint Petersburg, FL, United States	Manufacturer	0		0	api.fda.gov
Treace Medical Concepts, Inc.	Ponte Vedra, FL, United States	Manufacturer	0		0	api.fda.gov
Trillium Technology, Inc	Grass Lake, MI, United States	Manufacturer	0		0	api.fda.gov
Taiwan Main Orthopaedic Biotechnology Co., Ltd	Taichung City, Taiwan	Manufacturer	0		0	api.fda.gov
Terarecon, Inc.	Fremont, CA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Trice Imaging, Inc.	Miami, FL, United States	Manufacturer	0		0	api.fda.gov
TruBridge, Inc.	Mobile, AL, United States	Manufacturer	0		0	api.fda.gov
Ultromics, Ltd.	Oxford Oxfordshire, United Kingdom	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Valkyrie Bioscience, Inc	Lindon, UT, United States	Manufacturer	0		0	api.fda.gov
Vpix Medical, Inc.	Jung-gu Daejeon, South Korea	Manufacturer	0		0	api.fda.gov
Visual Medica	Ciudad Autonoma Buenos Aires Buenos Aires, Ciudad Autonoma de, Argentina	Manufacturer	0		0	api.fda.gov
Zimmer Surgical, Inc.	Dover, OH, United States	Contract manufacturer	0		0	api.fda.gov
iCRco Inc.	Goleta, CA, United States	Manufacturer	0		0	api.fda.gov
icometrix	Leuven Vlaams Brabant, Belgium	Manufacturer	0		0	api.fda.gov

Updated May 26, 2000. 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.