Skip to the page
Get started free

Data / Medical devices / System, Imaging, Pulsed Echo, Ultrasonic / United States

FDA-registered makers of System, Imaging, Pulsed Echo, Ultrasonic in the United States: 106 establishments

106 establishments in the United States are registered with the FDA to make System, Imaging, Pulsed Echo, Ultrasonic (product code IYO). 48 have a 510(k) clearance or PMA approval on file and 8 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers of this device in the United StatesWatch these makers
Device
System, Imaging, Pulsed Echo, Ultrasonic
Product code
IYO
Country
United States

Makers of System, Imaging, Pulsed Echo, Ultrasonic in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Volcano CorporationSan Diego, CA, United StatesComplaint file establishment, Specification developer10February 24, 2026030api.fda.gov
Bard Access Systems, Inc.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer9February 18, 2024000api.fda.gov
Volcano CorporationRancho Cordova, CA, United StatesManufacturer8February 24, 2026070api.fda.gov
DGH Technology, Inc.Exton, PA, United StatesManufacturer, Repackager or relabeler7July 31, 2017000api.fda.gov
Accutome, Inc.Malvern, PA, United StatesManufacturer5November 25, 2015000api.fda.gov
CIVCO Medical Instruments Co., Inc.Coralville, IA, United StatesManufacturer, Specification developer5January 23, 2015030api.fda.gov
Sonomed, Inc.Westbury, NY, United StatesManufacturer4April 1, 2014000api.fda.gov
Echonous, Inc.Redmond, WA, United StatesComplaint file establishment, Manufacturer, Remanufacturer3July 10, 2018000api.fda.gov
Fujifilm Sonosite,inc.Bothell, WA, United StatesComplaint file establishment, Manufacturer, Remanufacturer, Specification developer3December 29, 2011020api.fda.gov
Parker Laboratories, Inc.Fairfield, NJ, United StatesManufacturer3March 14, 1996020api.fda.gov
Philips Ultrasound LLCBothell, WA, United StatesComplaint file establishment, Manufacturer, Specification developer3December 13, 2017010api.fda.gov
Ray Vision Inc.Lake Forest, CA, United StatesRepackager or relabeler, Specification developer3November 18, 2021000api.fda.gov
Siemens Medical Solutions Usa, Inc.Issaquah, WA, United StatesComplaint file establishment, Manufacturer, Specification developer3June 12, 2024000api.fda.gov
Vomark Technologies IncWheeling, IL, United StatesRemanufacturer, Repackager or relabeler3October 22, 2010000api.fda.gov
Verathon Inc.Bothell, WA, United StatesManufacturer3September 15, 2017030api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesManufacturer2December 1, 2017000api.fda.gov
Butterfly Network, Inc.Burlington, MA, United StatesManufacturer, Specification developer2March 31, 2023000api.fda.gov
Dymax, Corp.Zelienople, PA, United StatesContract manufacturer, Remanufacturer2October 24, 2018000api.fda.gov
NEXT Medical Products CompanyBranchburg, NJ, United StatesContract manufacturer, Manufacturer2September 29, 1994000api.fda.gov
Philips Ultrasound LLCCambridge, MA, United StatesManufacturer, Specification developer2October 4, 2004000api.fda.gov
Sonavex, Inc.Baltimore, MD, United StatesManufacturer2April 23, 2025000api.fda.gov
Arcscan, Inc.Golden, CO, United StatesManufacturer1February 2, 2016000api.fda.gov
Best NomosPittsburgh, PA, United StatesComplaint file establishment, Manufacturer1February 9, 2005000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesManufacturer, Specification developer1September 18, 2015000api.fda.gov
BiomericaIrvine, CA, United StatesManufacturer, Repackager or relabeler1July 20, 1999000api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesComplaint file establishment, Manufacturer1September 18, 2015000api.fda.gov
Clear Guide MedicalBaltimore, MD, United StatesRepackager or relabeler, Specification developer1September 19, 2014000api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer1August 8, 1996000api.fda.gov
Dbmedx, Inc.Littleton, CO, United StatesManufacturer1December 15, 2014000api.fda.gov
Halo Medical TechnologiesBethlehem, PA, United StatesManufacturer1May 5, 2014000api.fda.gov
IMACOR, IncJericho, NY, United StatesComplaint file establishment, Manufacturer, Specification developer1June 24, 2008000api.fda.gov
Interson Corp.Pleasanton, CA, United StatesContract manufacturer, Manufacturer1April 17, 2007000api.fda.gov
Isono Health Inc.Sunnyvale, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1April 22, 2022000api.fda.gov
Kiltex Corp.Akron, OH, United StatesContract manufacturer, Manufacturer1July 25, 1996000api.fda.gov
Micro Medical Devices, Inc.Calabasas, CA, United StatesComplaint file establishment, Manufacturer1December 10, 2004000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer1October 22, 2010000api.fda.gov
MetriTrack, Inc.Oak Brook, IL, United StatesComplaint file establishment, Manufacturer1May 26, 2021000api.fda.gov
Nidek IncorporatedThe Colony, TX, United StatesManufacturer1May 3, 2002000api.fda.gov
Philips Ultrasound LLCReedsville, PA, United StatesContract manufacturer, Manufacturer, Specification developer1October 4, 2004000api.fda.gov
QT Imaging, Inc.Novato, CA, United StatesManufacturer1August 31, 2022000api.fda.gov
Reichert Inc.Depew, NY, United StatesManufacturer1March 21, 2003000api.fda.gov
Rivanna Medical, IncCharlottesville, VA, United StatesComplaint file establishment, Manufacturer1March 11, 2014000api.fda.gov
Sonivate Medical, Inc.Portland, OR, United StatesComplaint file establishment, Specification developer1February 25, 2020000api.fda.gov
The Prometheus GroupDover, NH, United StatesManufacturer1April 15, 2016000api.fda.gov
Tidi Products, LLCNeenah, WI, United StatesContract manufacturer, Specification developer1September 18, 2009000api.fda.gov
Ultravision CorporationNorth Palm Beach, FL, United StatesManufacturer1April 7, 2015000api.fda.gov
Vave Health IncSan Jose, CA, United StatesManufacturer, Specification developer1July 10, 2019000api.fda.gov
Verdure Imaging IncStockton, CA, United StatesManufacturer1October 7, 2024000api.fda.gov
Acertara Acoustic Laboratories, LLCLongmont, CO, United StatesContract manufacturer0000api.fda.gov
Acist Medical Systems, Inc.Eden Prairie, MN, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Acupac Packaging, Inc.Mahwah, NJ, United StatesContract manufacturer0000api.fda.gov
Advanced Tactile Imaging, Inc.Trenton, NJ, United StatesManufacturer0000api.fda.gov
Advantech CorporationMilpitas, CA, United StatesContract manufacturer0000api.fda.gov
Aesthetics Biomedical Inc.Phoenix, AZ, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Amphenol DC ElectronicsSan Jose, CA, United StatesManufacturer0000api.fda.gov
Apical InstrumentsRedwood City, CA, United StatesContract manufacturer0000api.fda.gov
Abbott MedicalWestford, MA, United StatesManufacturer0000api.fda.gov
Bard Shannon LimitedHumacao, PR, United StatesContract manufacturer0000api.fda.gov
Benchmark Electronics, Inc.Winona, MN, United StatesContract manufacturer0000api.fda.gov
BioticsAI, Inc.San Francisco, CA, United StatesManufacturer0000api.fda.gov
Carl Zeiss Meditec IncDublin, CA, United StatesManufacturer0000api.fda.gov
CDR Manufacturing, Inc., DBA KeytronicOakdale, MN, United StatesContract manufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Edge Life Technologies, LLCDoral, FL, United StatesManufacturer0000api.fda.gov
Endosound IncPortland, OR, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Exo Imaging, Inc.Santa Clara, CA, United StatesSpecification developer0000api.fda.gov
Freeland Systems, LLCCarmel, IN, United StatesManufacturer0000api.fda.gov
FUJIFILM Healthcare Americas CorporationLexington, MA, United StatesManufacturer0000api.fda.gov
FUJIFILM Healthcare Americas CorporationTwinsburg, OH, United StatesSpecification developer0000api.fda.gov
GE Medical Systems Ultrasound & Primary Care Diagnostics LLCNoblesville, IN, United StatesManufacturer, Remanufacturer0000api.fda.gov
GE Medical Systems Ultrasound and Primary Care Diagnostics LLCWauwatosa, WI, United StatesManufacturer, Specification developer0020api.fda.gov
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLCWaukesha, WI, United StatesSpecification developer0000api.fda.gov
Ge Parallel Design, Inc.Phoenix, AZ, United StatesManufacturer0000api.fda.gov
Granite Microsystems, Inc.Mequon, WI, United StatesContract manufacturer0000api.fda.gov
Gynesonics, Inc.Redwood City, CA, United StatesManufacturer0000api.fda.gov
HM Product Solutions, Ltd.Hartland, WI, United StatesContract manufacturer0000api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesManufacturer0000api.fda.gov
Ivu Imaging CorporationSouthlake, TX, United StatesManufacturer0000api.fda.gov
Jointvue, LLCKnoxville, TN, United StatesManufacturer0000api.fda.gov
Jabil Inc.Auburn Hills, MI, United StatesContract manufacturer0000api.fda.gov
Katecho LLCDes Moines, IA, United StatesContract manufacturer0000api.fda.gov
Kimball Solutions Jasper, Inc.Jasper, IN, United StatesContract manufacturer0000api.fda.gov
Minnetronix, Inc.Saint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Neo Medical Usa, Inc.San Jose, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Nipro Vascular Innovations Americas, Inc.Bedford, MA, United StatesManufacturer0000api.fda.gov
Provisio Medical Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Phillips-Medisize Costa Mesa LLCCosta Mesa, CA, United StatesContract manufacturer0000api.fda.gov
Scientific Molding Corporation, Ltd. Dba SMC Ltd.Santa Rosa, CA, United StatesContract manufacturer0000api.fda.gov
Seno Medical Instruments, Inc.San Antonio, TX, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Sound Technology Inc.State College, PA, United StatesManufacturer0000api.fda.gov
Spectrawave, Inc.Bedford, MA, United StatesManufacturer0000api.fda.gov
Siemens Medical Solutions USA, Inc.Plymouth Meeting, PA, United StatesManufacturer, Specification developer0000api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.Saint Paul, MN, United StatesManufacturer0000api.fda.gov
Teratech Corp.Burlington, MA, United StatesManufacturer0000api.fda.gov
TransducerworksCentre Hall, PA, United StatesContract manufacturer0000api.fda.gov
Trice MedicalMalvern, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Ulthera IncRaleigh, NC, United StatesSpecification developer0000api.fda.gov
Vascular Solutions LLCMaple Grove, MN, United StatesManufacturer0000api.fda.gov
Vivemos, LLCKennewick, WA, United StatesContract manufacturer0000api.fda.gov
VLV Associates, Inc.Whippany, NJ, United StatesContract manufacturer0000api.fda.gov
Vonco Products, LLCFortville, IN, United StatesContract manufacturer0000api.fda.gov
X9 Inc.Wallingford, CT, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Yorlabs, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesContract manufacturer0000api.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.