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Medivest Group: FDA-registered device maker in Dinnington East Riding of Yorkshire, United Kingdom, 14 510(k) clearances and 2 PMA approvals

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

Medivest Group is registered with the FDA (registration 3027339477) in Dinnington East Riding of Yorkshire, United Kingdom. It lists 11 device types. The FDA files 14 510(k) clearances and 2 PMA approvals under its listings, the newest dated September 4, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3027339477
Address: unit 8 Kingfisherway, Dinnington East Riding of Yorkshire, United Kingdom, S25 3AF
Owner or operator: Medivest Group (10089556)
Roles: Exporter to the US
First device listed: December 18, 2023
Registered through: 2026
Brand names listed: DISCOVERY MR750W 3T, GE 1.5T EXCITE HDXT MR, GE Discovery 670 SPECT/CT, GE Discovery 750HD CT, GE LightSpeed VCT 64 Slice CT, GE OPTIMA 660 CT, GE Revolution CT, GE SIGNA Artist and more

Devices it lists

Device	Product code	Class	Role	Source
Coil, Magnetic Resonance, Specialty	MOS	2	Exporter to the US	accessdata.fda.gov
Digital Breast Tomosynthesis	OTE	3	Exporter to the US	accessdata.fda.gov
Full Field Digital, System, X-Ray, Mammographic	MUE	2	Exporter to the US	accessdata.fda.gov
Image-Intensified Fluoroscopic X-Ray System, Mobile	OXO	2	Exporter to the US	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Exporter to the US	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Exporter to the US	accessdata.fda.gov
System, Nuclear Magnetic Resonance Spectroscopic	LNI	2	Exporter to the US	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Stationary	KPR	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	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
September 4, 2020	K202238	SIGNA Artist	LNH	Substantially Equivalent	Ge Healthcare (Tianjin) Company Limited	accessdata.fda.gov
December 16, 2016	K163213	Revolution CT	JAK	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
August 8, 2016	K160743	Philips Ingenuity CT	JAK	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
August 21, 2014	K142006	SYMBIA 6.0	KPS	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
August 30, 2013	K131576	OPTIMA CT660	JAK	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
May 23, 2013	K130115	DISCOVERY MR750W 3.0T	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
June 12, 2012	K120833	DISCOVERY CT750 HD	JAK	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
April 6, 2012	K120613	OEC 9900 ELITE	OXO	Substantially Equivalent	Ge Healthcare Surgery GE Oec Medical Systems, Inc.	accessdata.fda.gov
December 10, 2009	K093514	DISCOVERY MODEL NM/CT 670	KPS	Substantially Equivalent	Ge Medical Systems F.I. Haifa	accessdata.fda.gov
August 22, 2008	K081722	YSIO	KPR	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
March 17, 2006	K060631	BIOGRAPH 64 AND BIOGRAPH 40	KPS	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
September 21, 2005	K052293	GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
June 1, 2005	K051133	ARCADIS AVANTIC	OXO	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
March 1, 2004	K040372	LIGHTSPEED 7.0 CT SCANNER SYSTEM	JAK	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
February 11, 2011	P080003	SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM	OTE	10	November 24, 2025	accessdata.fda.gov
March 15, 2002	P010025	LORAD DIGITAL BREAST IMAGER	MUE	17	November 16, 2010	accessdata.fda.gov

Compare with other makers

Updated November 24, 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.