SEDECAL S.A.

FDA Device Registration & Listing · ALGETE Madrid (Province), ES · Registration 9617251

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9617251
FEI Number
3002495042
Entity Name
SEDECAL S.A.
City/State/Country
ALGETE Madrid (Province), ES
Establishment Address
PELAYA, 9 POL., POL. IND. RIO DE JANEIRO, ALGETE Madrid (Province) 28110, ES
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
SEDECAL S.A. (Owner Number: 9039772)
Owner / Operator Contact Address
PELAYA, 9 POL., POL. IND. "RIO DE JANEIRO", ALGETE, ES-M 28110, ES
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SM-V PhoeniX Odyssey+ Odyssey SPL-HF-4 SPSL-HF-4-APR SPSL-HF-4 SPL-HF-2 NOVA FA SPSLW8 SPSLW4 MOBILETT Impact SPSL8HC SPSL4HC SM-IV Aero DR TX m01 mKDR Xpress Sedecal X Plus Lp Plus (Digital) Sedecal X Plus LP Plus Multi Rad Chiropro Multi Rad NET Millennium Sedecal X Plus Lp Challenge-X SM-40HF-Batt SM-20HF-Batt SM-32HF-Batt SM-50HF-Batt Nova System SHF-XXXX-M SHF-XXX Series SHF-XXXX Series SHF-XXX-C Series SHF-XXXX-C Series SHF-XXXX PSU Series SHFR100,SHFR300,SHFR400,SHFR500,SHFR600,SHFR800 SHF-XXXX-MPSTA SHF-XXX PSU Series Multi RAD Sedecal X Plus Lp Millennium MILLENNIUM TWBS-TILT MULT-WBS MILL-WBS MULTIRAD Radiography 7000 M Nova Millennium Multirad Millennium Plus FM Plus Mobilett Mira Max Soltus 500 Soltus 450 Multirad NET Multirad Proteus XR/f Model ET Proteus XR/f Model ST Mobilett Elara Max

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2022-12-09
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2019-09-25
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2019-09-25
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2013-05-06
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2015-07-03
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2012-08-08
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2012-08-08
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2023-09-18
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2023-09-18
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2019-09-12
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2019-09-12
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2023-08-29
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2022-07-18
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2022-07-18
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2011-05-27
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2007-10-19
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2020-10-08
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2020-10-08
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2009-05-29
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2008-12-12
IZO Generator, High-Voltage, X-Ray, Diagnostic Radiology Class 1 892.1700 1999-11-30
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2007-10-19
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2007-10-19
IXY Holder, Radiographic Cassette, Wall-Mounted Radiology Class 1 892.1880 2008-02-14
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2019-08-05
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2019-08-05
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2024-02-19
IYB Tube Mount, X-Ray, Diagnostic Radiology Class 1 892.1770 2008-02-14
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2010-01-12
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2019-07-02
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2019-11-18
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2019-11-18
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2021-02-02
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2021-02-02
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2019-07-02

Official Correspondent

No official correspondent registered.

US Agent Details

Devan Moser Business: Sedecal USA Inc. Email: DMOSER@SEDECALUSA.COM Phone: (847) 3946960

Related Public Records

Same Entity

SEDECAL S.A.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3006972752 Stephanix La Ricamarie Auvergne-Rhone-Alpes, FR
3011347852 A.T.S. Applicazione Tecnologie Speciali s.r.l. Torre de Roveri Bergamo, IT
3009868110 Metaltronica Spa Pomezia Roma, IT

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K153059 Minxray, Inc. HF1202H PowerPlus Portable X-ray Equipment 2016-02-02
K070563 Vidar Systems Corp. VIDAR VISION 2000 2007-03-16
K190691 Pixxgen Corporation Pixx2430 Digital Diagnostic X-Ray Receptor Panel 2019-04-04
K150150 Rayence Co., Ltd. 1717SGN / 1717SCN Digital Flat Panel X-ray Detector 2015-03-27
K140771 Philips Medical Systems Dmc GmbH PHILIPS ELEVA WORKSPOT 2014-04-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-1470-2023 FUJIFILM Healthcare Americas Corporation 2
FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Z-3158-2024 FUJIFILM Healthcare Americas Corporation 2
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
Z-0005-2009 Toshiba American Medical Systems Inc 2
Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007 AGFA Corp. 2
CR DX-S, Image Intensified Fluoroscopic X-ray system.
Z-0002-2009 GE Medical Systems, LLC 2
Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617251. Last updated year: 2026. Please use registration number 9617251 when referencing this establishment in official correspondence.
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