Search Results
Found 6 results
510(k) Data Aggregation
K Number
K002062Device Name
SAMSUNG 10DR IMPLANT SYSTEM
Manufacturer
SAMSUNG SDS CO., LTD
Date Cleared
2000-11-09
(126 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
SAMSUNG SDS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K992426Device Name
RAYPAX WEB CLINICAL SYSTEM
Manufacturer
SAMSUNG SDS CO., LTD
Date Cleared
1999-10-13
(84 days)
Product Code
LMD
Regulation Number
892.2020Why did this record match?
Applicant Name (Manufacturer) :
SAMSUNG SDS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Web Clinical System is intended for the management and displaying of x-ray images, other radiological objects, and information. It can manage images from different modalities, single and multiple file servers, and interfaces to various Radiological Information Systems (RIS), image storage and printing devices using DICOM or similar interface standards within the system or across computer networks at distributed locations.
Device Description
The Web-Clinical System (WCS) is a component of the RAYPAX System, a PACS solution by Samsung or can be a separate device for other manufacturer's PACS. The WCS is a system for managing radiological images and data by retrieving and browsing medical images through the World Wide Web, (Internet), a clients Intranet or over computer networks.
Ask a Question
K Number
K992306Device Name
SAMSUNG RAYPAX DISPLAY WORKSTATION
Manufacturer
SAMSUNG SDS CO., LTD
Date Cleared
1999-09-22
(75 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SAMSUNG SDS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Samsung RAYPAX™ Display Workstation is a device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound Systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, film scanners, imaging gateways, or other imaging sources). Images and data can be stored, communicated, processed, and displayed within the workstation or across computer networks at distributed locations.
The typical users of this system are trained professionals, including but not limited to physicians, nurses, and medical technicians.
Device Description
The Display Workstation is one of the components of the RAYPAX, a PACS solution by Samsung or can be a separate device for other manufacturer's PACS. The Display Workstation provides image-processing functions and workflow for the radiology department for medical images that are acquired and stored in the RAYPAX image server in DICOM 3.0 format.
Furthermore, the Display Workstation can transfer medical images stored in RAYPAX system to other PACS through a DICOM compatible network and can export images to other applications in bitmap format.
Ask a Question
K Number
K992131Device Name
SAMSUNG RAYPAX LONG TERM ARCHIVE
Manufacturer
SAMSUNG SDS CO., LTD
Date Cleared
1999-09-13
(82 days)
Product Code
LMB
Regulation Number
892.2010Why did this record match?
Applicant Name (Manufacturer) :
SAMSUNG SDS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Samsung RAYPAX™ Archive will be used to store & retrieve digital medical images and information about the images. The typical users are trained medical professionals.
Device Description
The Samsung LTA can be part of RAYPAX PACS or can be a separate device for other manufacturer's PACS. It is used to store & retrieve digital medical images and information about the images using the DICOM 3.0 communication standard. RAYPAX LTA differs from some other PACS systems by having an additional storage unit management for medical images. The RAYPAX database stores and manages examination and patient information while the RAYPAX storage devices store and manage the medical images. To gather medical image data, RAYPAX uses DICOM 3. Using DICOM 3.0, medical-image producing equipment requests to store medical-image data in the DICOM gateway, which acts as the gateway to the Short Term Storage (STS). The DICOM gateway, after receiving such a request, stores the medical images in the STS. All the medical images that come into the STS are stored in the Long Term Archive. If there are images that need to be highly accessible, the LTA Manager transfers it to the STS. The RAYPAX system administrator sets this transferring authority.
Ask a Question
K Number
K992112Device Name
SAMSUNG RAYPAX FILM DIGITIZER
Manufacturer
SAMSUNG SDS CO., LTD
Date Cleared
1999-09-09
(79 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SAMSUNG SDS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Samsung RAYPAX™ Film Digitizer is a digitizer intended to convert medical images and data into digital signals. The digital data can be stored, communicated. processed and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
Device Description
The Samsung Film Digitizer (FD) can be part of the RAYPAX PACS (Picture Archiving and Communication System), or can be a separate device for other manufacturer's PACS. It converts analog films to digitized images in the DICOM (Digital Imaging and Communications in Medicine) Standard 3 compatible files. In addition, FD supports a patient information search, an image information management, digitization, a DICOM file generation, a simple image processing, and DICOM file transferring to other components of the PACS.
Ask a Question
K Number
K991537Device Name
SAMSUNG RAYPAX SYSTEM
Manufacturer
SAMSUNG SDS CO., LTD
Date Cleared
1999-07-06
(64 days)
Product Code
LMD
Regulation Number
892.2020Why did this record match?
Applicant Name (Manufacturer) :
SAMSUNG SDS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Samsung RAYPAX™ is a device that receives digital images and data from various sources (including but not limited to CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Device Description
The Samsung RAYPAX™ system handles various objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. PACS transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.
Ask a Question
Page 1 of 1