FDA.reportPublic FDA data

Proton B.V.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30129870013012987001Proton B.V.1N2026-01-01Dr. Nolenslaan 157/J GM Sittard Limburg NL 6136

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2011791670937787K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)IYN2026-04-06
2011792043312261K161168MyLabSix Ultrasound SystemIYN2016-09-02
2011791822731516K101605MYLABONE ULTRASOUND SYSTEMIYN2010-08-31
2011791044019387K083882MYLABFIVEIYN2009-01-30
2011791623472554K070903MYLAB40ITX2007-07-02
2011792024998598K061755MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEMIYO2006-08-07
2011791648449399K041675PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMSIYN2004-07-23
2011791744881519K033604TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50LIYO2003-12-15
2011791941492775K02011250S TRINGA ULTRASOUND IMAGING SYSTEMIYO2002-04-19
2011791804982424K003292260 CORVUSIYO2001-01-05
2011791044019387
2011791049176802
2011791136211123
2011791255902897
2011791300593887
2011791405349657
2011791447452296
2011791449610573
2011791455139582
2011791463807627
2011791499531629
2011791565429017
2011791623472554
2011791696583916
2011791751804346
2011791821442607
2011791822731516
2011791864656833
2011791971081509
2011792024455148
2011792032393970
2011792043312261
2011792054491794

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN52026-04-06
IYO42006-08-07
ITX12007-07-02