Data / Medical devices / Netherlands / Proton B.V.

Proton B.V.: FDA-registered device maker in GM Sittard Limburg, Netherlands, 1 510(k) clearance

Name: Proton B.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Proton B.V. is registered with the FDA (registration 3012987001) in GM Sittard Limburg, Netherlands. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 6, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012987001
Address: Dr. Nolenslaan 157/J, GM Sittard Limburg, Netherlands, 6136
Owner or operator: ESAOTE S.P.A. (8021005)
Roles: Contract manufacturer, Manufacturer
First device listed: June 3, 2011
Registered through: 2026
Brand names listed: 6200 Ultrasound System, 6250 Ultrasound System, 6400 Model, 6420, 6425, 6430 US System, 6440 Ultrasound System, 6450 Model and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Contract manufacturer, Manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 6, 2026	K253288	6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)	IYN	Substantially Equivalent	Esaote, S.p.A.	accessdata.fda.gov

Compare with other makers

Updated April 6, 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.