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Pilson Direct Trading Limited: FDA-registered device maker in Newcastle Newcastle upon Tyne, United Kingdom, 14 510(k) clearances

Name: Pilson Direct Trading Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Pilson Direct Trading Limited is registered with the FDA (registration 3011763071) in Newcastle Newcastle upon Tyne, United Kingdom. It lists 7 device types. The FDA files 14 510(k) clearances under its listings, the newest dated November 17, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011763071
Address: 25 Thames Street Gateshead, Newcastle Newcastle upon Tyne, United Kingdom, NE8 3SP
Owner or operator: Pilson Direct Trading Limited (10049953)
Roles: Exporter to the US
First device listed: January 31, 2023
Registered through: 2026
Brand names listed: ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System and accessories, ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System, ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM AND ACCESSORIES, ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER, BK500, BK3500, BK3000 Ultrasound system, EPIQ CVX , EPIQ 5, EPIQ 7, EPIQ Elite, Affiniti 30, Affiniti 50, Affiniti 70 Ultrasound System and accessories, EPIQ Cvx and Series Diagnostic Ultrasound System; Affiniti Cvx and Series Diagnostic Ultrasound System, GE Ultrasound Transducers and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Exhaust, Surgical	FYD	2	Exporter to the US	accessdata.fda.gov
Automated Radiological Image Processing Software	QIH	2	Exporter to the US	accessdata.fda.gov
Biopsy Needle Guide Kit	OIJ	2	Exporter to the US	accessdata.fda.gov
Catheter, Ultrasound, Intravascular	OBJ	2	Exporter to the US	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Exporter to the US	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Exporter to the US	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Exporter to the US	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
November 17, 2025	K253487	ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System	IYN	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
October 9, 2025	K251651	EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, LLC	accessdata.fda.gov
September 26, 2023	K232617	ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System	IYN	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
May 12, 2023	K231190	EPIQ Series Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, LLC	accessdata.fda.gov
April 11, 2023	K223830	Ultrasound System 2300	IYN	Substantially Equivalent	Bk Medical Aps	accessdata.fda.gov
July 27, 2018	K181485	EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
May 15, 2014	K141093	6VT-D ULTRASOUND TRANSDUCER	ITX	Substantially Equivalent	Ge Vingmed Ultrasound AS	accessdata.fda.gov
March 28, 2014	K134016	ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER	IYN	Substantially Equivalent	Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical	accessdata.fda.gov
September 24, 2013	K131937	VOLUSON I/E	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
May 13, 2011	K111227	ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Aloka Co., Ltd.	accessdata.fda.gov
October 22, 2010	K102991	M5 DIAGNOSTIC ULTRASOUND SYSTEM	IYO	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
June 17, 2010	K093466	HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS	IYO	Substantially Equivalent	Hitachi Medical Systems America, Inc.	accessdata.fda.gov
July 12, 2006	K061682	GE VOLUSON E8 ULTRASOUND SYSTEM	IYO	Substantially Equivalent	General Electric Co.	accessdata.fda.gov
November 29, 2001	K012991	NEPTUNE WASTE MANAGEMENT STSTEM	FYD	Substantially Equivalent	Stryker Instruments	accessdata.fda.gov

Compare with other makers

Updated November 17, 2025. 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.