Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004016520

FEI Number

3004016520

Entity Name

SANMINA- SCI ISRAEL MEDICAL SYSTEMS LTD.

City/State/Country

Maalot-Tarshiha Northern, IL

Establishment Address

5 Haroshet st., Koren Industrial Park, Maalot-Tarshiha Northern 2101802, IL

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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Renaissance System Mazor X SA Reduction Tube, 10 pack TX eco Cable Mazor X Renaissance Accessories Mazor X Accessories FFRangio System Pure-Vu Workstation Controller with Foot Pedal TRUPULSE Remote Monitor TRUPULSE Generator Capnostream35 Portable Respiratory Monitor Renaissance System with Brain Application Capnostream 35 Portable Respiratory Monitor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-05-04
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-05-04
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-02-23
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-02-23
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-02-19
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-02-19
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2023-02-01
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2023-02-01
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-12-25
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-12-25
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-12-20
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-12-20
QEK	Angiographic Coronary Vascular Physiologic Simulation Software	Cardiovascular	Class 2	870.1415	2020-05-04
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-09-29
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Unknown	Class 3	N/A	2024-11-13
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-09-08
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2020-09-08
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2020-09-08
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-05-04
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-05-04
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2016-03-27
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2016-03-27
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2016-03-27

Official Correspondent

No official correspondent registered.

US Agent Details

Jeffrey Stahl Business: Sanmina Email: jeffrey.stahl@sanmina.com Phone: (256) 4794797

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
3007923088	Sanmina-SCI Systems (Malaysia) Sdn Bhd	Perai Pulau Pinang, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004016520. Last updated year: 2026. Please use registration number 3004016520 when referencing this establishment in official correspondence.