Sanmina-SCI Systems de Mexico SA de CV

FDA Device Registration & Listing · Carr. Chapala-Guadalajara Jalisco, MX · Registration 3006544299

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
3006544299
FEI Number
3006544299
Entity Name
Sanmina-SCI Systems de Mexico SA de CV
City/State/Country
Carr. Chapala-Guadalajara Jalisco, MX
Establishment Address
Km 15.5 No. 29, Plant 06, Carr. Chapala-Guadalajara Jalisco 45640, MX
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Sanmina Corporation (Owner Number: 2129538)
Owner / Operator Contact Address
13000 S. Memorial Pkwy, --, Huntsville, AL 35803, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

O-arm® O2 Imaging System O-arm™ O2 Imaging System O-arm O2 Imaging System O-arm O2 Imaging System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2018-03-28
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2024-08-08
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2024-08-08
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2024-08-08
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2023-11-15
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2023-11-15
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2023-11-15
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2023-11-15
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2023-11-15
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2023-11-15

Official Correspondent

No official correspondent registered.

US Agent Details

Jeffrey Stahl Business: Sanmina Email: jeffrey.stahl@sanmina.com Phone: (256) 8824125

Related Public Records

Same Entity

Sanmina Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004139819 Sanmina Ireland UC FERMOY, CORK Munster, IE
3004201275 SANMINA-SCI AB SJALEVAD Vasternorrland, SE
3009609218 Sanmina Corporation Carrollton, TX, US
3007867838 Sanmina SAN JOSE, CA, US
3004016520 SANMINA- SCI ISRAEL MEDICAL SYSTEMS LTD. Maalot-Tarshiha Northern, IL

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K163715 Philips Medical Systems Nederland B.V. Allura Xper R9 2017-01-26
K060344 Breakaway Imaging, LLC O-ARM IMAGING SYSTEM 2006-03-29
K982706 Philips Medical Systems, Inc. PHILIPS BV300 SERIES RELEASE 2.1 1998-09-02
K863853 Superior Medical Products EAZY COVERS 1987-03-06
K953974 Medivision Medical Imaging, Ltd. CAMVISION 1000 1996-09-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands 2
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0002-2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands 2
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0003-2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands 2
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0004-2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands 2
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0005-2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands 2
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Similar Registrations

Registration Number Establishment Name Location
3021027284 ANGIOWAVE IMAGING, INC. Concord, MA, US
3042175844 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BEST Noord-Brabant, NL
3027373189 LIBERTY GLOBAL, LLC Scottsdale, AZ, US
3033527282 Philips India Limited - Image Guided Therapy Systems Business Unit Bengaluru Karnataka, IN
9614698 CANON INC. OTAWARA-SHI Tochigi, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006544299. Last updated year: 2026. Please use registration number 3006544299 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.