Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008962177

FEI Number

3008962177

Entity Name

GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A.

City/State/Country

Valencia, ES

Establishment Address

C/Jeronimo de Monsoriu 92 Bajo Izda, Valencia 46022, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A. (Owner Number: 10035514)

Owner / Operator Contact Address

Jeronimo de Monsoriu n 92 Bajo Izq, Valencia, ES-V 46022, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MAMMI BREAST PET MAMMI SINGLE RING BREAST PET MAMMI BREAST PET MAMMI SINGLE RING BREAST PET MAMMI DOUBLE RING BREAST PET SENTINELLA 102 HORUS SENTINELLA 102 SENTINELLA 102 SENTINELLA 102 HORUS GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A. WPROBE LAP WPROBE STD WPROBE Hi-S WPROBE GAMMAPRO LAP GAMMAPRO Hi-S GAMMAPRO STD GAMMAPRO ANGLED

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2014-07-10
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2016-08-19
IYX	Camera, Scintillation (Gamma)	Radiology	Class 1	892.1100	2014-12-30
IYX	Camera, Scintillation (Gamma)	Radiology	Class 1	892.1100	2016-08-19
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2023-12-20
IZD	Probe, Uptake, Nuclear	Radiology	Class 1	892.1320	2012-01-18

Official Correspondent

Ivan Navarro

US Agent Details

Nicolas Fontanillas Business: Spain US Chamber of Commerce Email: fda@spainchamber.org Phone: (305) 3585988

Related Public Records

Same Entity

GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033956	Is2 Research, Inc.	MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)	2004-01-20
K923309	GE Medical Systems	ARGUS PET SYSTEM	1992-09-29
K101768	Miegmbh	MIE SCINTRON GAMMA CAMERA SYSTEMS	2010-10-05
K942580	Neoprobe Corp.	NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES	1995-02-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2016	Toshiba American Medical Systems Inc	2	Celesteion PCA-9000A/2 PET/CT System
Z-0012-05	General Electric Med Systems LLC	2	Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.
Z-0013-2007	Philips Medical Systems (Cleveland) Inc	2	Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. PET/CT Computed tomography systems.
Z-0014-2007	Philips Medical Systems (Cleveland) Inc	2	Brilliance(a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535 670 73181. Brilliance 16 Slice, Model #4535 670 78851. Brilliance CT 16 Power, Model #4535 670 23331. Brilliance CT 40 Slice, Model #4550 110 04011. Brilliance CT Big Bore, Model #4535 670 88051. Computed tomography systems.
Z-0024-2014	GE Healthcare, LLC	2	GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.

Similar Registrations

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9614698	CANON INC.	OTAWARA-SHI Tochigi, JP
3011950073	United Imaging Healthcare North America, Inc	Houston, TX, US
1423253	SIEMENS MEDICAL SOLUTIONS USA, INC.	Hoffman Estates, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008962177. Last updated year: 2026. Please use registration number 3008962177 when referencing this establishment in official correspondence.