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Found 22 results
510(k) Data Aggregation
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?
Product Code :
LMB
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.
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K Number
K984405Device Name
ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000
Manufacturer
INTRACOM CORP.
Date Cleared
1999-02-08
(61 days)
Product Code
LMB
Regulation Number
892.2010Why did this record match?
Product Code :
LMB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EchoLive™ medical image management device family is designed for use in all medical specialties including, but not limited to, radiology, cardiology, gynecology, ENT, neurology, pediatrics, podiatry, chiropractic, general surgery, oral surgery and dentistry. The device may be used in medical offices and health care facilities, to facilitate access to clinical images and information, both archived and dynamic, in distributed locations over intranets, LANs, Internet, direct or dial dial-up telephone lines. The system may transmit a wide range of data including, but not limited to, Sonographs (Ultrasound images), Computer Tomography (CT), Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET). In addition the device may communicate standard audio, video and digital transmissions and recordings, providing complete clinical imaging handling, providing direct capture, retrieval, storage, and direct transmission and printing of images, reports, and patient information.
Device Description
The EchoLive™ medical image management device family is a PACS capable of digital real-time simulcast transmission of medical images. Each model varies in the particular features and capabilities it offers the medical professional.
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K Number
K983447Device Name
WISE (II) IMAGE MANAGEMENT SYSTEM
Manufacturer
SECTRA-IMTEC AB
Date Cleared
1998-10-29
(29 days)
Product Code
LMB
Regulation Number
892.2010Why did this record match?
Product Code :
LMB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sectra AB WISE II Image Management System device 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 devicesusing DICOM or similar interface standards.
Device Description
WISE II is a system for managing digital radiological images. This includes image storage and searching for images in archives and retrieving image for re-consultation. WISE II generally provides functions to:
- Access information related to requests, examinations and images .
- Create, move, copy and delete folders and examination folders .
- Add images to and delete images from examinations .
- File examinations to the archives and retrieve examinations from the archives ●
- Retrieve examinations from DICOM conformant archives ●
- Manage images stored on multiple file servers
- Provide services (DICOM, WWW, etc) to clients via WISE gateways ●
- . Interface RIS for relational integrity
- . Send and retrieve images (teleradiology)
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K Number
K980243Device Name
PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)
Manufacturer
PARAMETER DEVELOPMENTS, INC.
Date Cleared
1998-04-03
(70 days)
Product Code
LMB
Regulation Number
892.2010Why did this record match?
Product Code :
LMB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DICOM Archival Server (DAS)/DICOM IntraNET Service (DIS), software product, provides for the centralized management and storage of radiographic studies, replacing or augmenting the historical film-based processes.
Device Description
The DICOM Archival Server (DAS) software product provides for the centralized management and storage of radiographic studies, replacing or augmenting the historical filmbased processes. The operating system utilizes Microsoft @ Windows NT @ Release 4.0 and later. This environment provides for all communication (i.e. TCP/IP), file storage (e.g. NTFS), security management, and display management processes. It also insulates the DAS from detail hardware management processes, allowing customers to make whatever choices in these areas best serve them. This environment supports a variety of back-up/restore processes which may be used at the customer's discretion. The Microsoft© SQL Server product is used as the primary management component for the archive contents and for responding to requests. whether they be in the form of SQL Server direct requests or via the DICOM Query/Retrieve process. This software-only product is fully DICOM-3.0 compliant for the following DICOM Service Classes: Verification (SCP), Storage (SCP and SCU), Query/Retrieve (SCP), Print (SCU), Patient Management (SCU), Study Management (SCU), Results Management (SCU). This product consists only of software and executes in a Windows© NT© environment on Intel© platforms. This product, when combined with appropriate server platform hardware and operating system, falls into the FDA proposed designation of a PACS system as Class II (Special Controls). The following attributes are noted: this product accepts, stores and transfers images; no image processing is done by this product; no compressed images are accepted for storage by this product; this product will supply compressed images as requested by client products, at the level of compression requested by those clients; no image viewing is provided by this product; the reliability of the product is dependent upon the hardware on which the software is installed, and is determined by the installation; disaster recovery attributes of an installation are dependent upon installationdetermined policies, and are totally under the control of the installation. The DAS product contains the following advanced features to facilitate rapid movement of images to desired targets within a PACS system: automatic image forwarding and automatic image printing. Automatic image forwarding enables a policy-managed forwarding process wherein each image received by the DAS will automatically be forwarded to one or more target workstations based upon the following image contents: modality station name, body part, referring physician, and modality type. Automatic image printing is an extension of the automatic forwarding process wherein the forwarding target is a DICOM Print Service Class Provider. The DICOM IntraNET Service (DIS) software product provides for centralized distribution of stored radiographic studies. DIS is an integrated client-server software system designed to allow secured access to radiographic images by licensed medical professionals. The software's server and client ends rely on off-the-shelf Windows NT software with compatible Intel hardware. The client end accesses images through a WEB Browser similar to Microsoft's Internet Explorer through a Query/Retrieve process. The DIS system becomes an extended Viewer attached to a secured internal network or an extended secured Intranet using TCP/IP communications protocol. Full resolution, lossless images are always available to the Client Browser. If lossy compression where used, similar to our equivalent products listed in item 10; Kodak, Base-Ten, or Autocyt, we would recommend that they be used for secondary viewing only and not for diagnostic interpretation. This DIS software is intended to provide the means for medical professionals to display data generated by medical scanning devices on a personal computer or workstation. Competent healthcare professionals would reasonably be expected to exercise judgment in use of this information.
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K Number
K973463Device Name
OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE
Manufacturer
OTECH, INC.
Date Cleared
1997-12-02
(81 days)
Product Code
LMB, CLA
Regulation Number
892.2010Why did this record match?
Product Code :
LMB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Olicon Imaging Systems, NT Archive Systems stores and retrieves digital images together with information about the DICOM standard network protocol. communicates with other devices via the DICOM standard network protocol.
Device Description
The NT ARCHIVE SYSTEM is a device for filing digital radiological images for storage and retrieval. The system design is layered with three storage technologies; magnetic, magneto-optical and DLT tape.
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K Number
K973413Device Name
ID. STORE (RELEASE 2.0)
Manufacturer
I.S.G. TECHNOLOGIES, INC.
Date Cleared
1997-11-25
(77 days)
Product Code
LMB
Regulation Number
892.2010Why did this record match?
Product Code :
LMB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ID.Store is a software device intended to direct the lossless archival storage and retrieval, including the use of pre-fetching and auto-routing capabilities, of digital medical images within a Picture Archiving and Communications System (PACS).
ID.Store may be used for the permanent storage and subsequent retrieval of any medical imaging data presented in DICOM or other supported format, within a Picture Archiving and Communications System (PACS).
Device Description
The ID.Store device is a software package composed of several application modules which work in tandem using a distributed storage architecture to control the archival storage and retrieval of digitized medical images. The ID.gate (gateway), ID.store (archiving), and ID.dbs (image database manager) modules communicate with each other using the dedicated administrative communication protocol ImageTalk. Permanent archival storage media supported include CD-R, WORM, MOD/WORM, DVD, etc. Recommended hardware are standard general purpose equipment, e.g. Sun Sparc or UltraSparc CPU's, and RAID devices for temporary data storage.
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K Number
K972380Device Name
KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL)
Manufacturer
EASTMAN KODAK COMPANY
Date Cleared
1997-09-11
(77 days)
Product Code
LMB
Regulation Number
892.2010Why did this record match?
Product Code :
LMB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KODAK DIGITAL SCIENCE (KDS) Medical Image and Information Library is a DICOM conformant archival product designed for use within a Picture Archiving and Communication System (PACS). The system utilizes a prefetching Archiving and Sommercess to previous imagery.
Device Description
The system consists of three main components: 1) the host CPU (a Sun SPARCstation 5, SPARCstation 20, or UltraSparc) with pre-installed proprietary software, 2) the magnetic cache, a Sun SPARC storage Redundant Array of Inexpensive Disks (RAID) subsystem, and 3) a KODAK DIGITAL SCIENCE ADL 150 writeable CD jukebox or a Digital Linear Tape (DLT) library. The RAID subsystem, combined with either the CD jukebox or DLT library, are managed by a hierarchical storage library that presents these two subsystems to the system software running on the host CPU as a single, very large filesystem. The power supply provides power to operate the unit from a line voltage for 100, 120, 220, or 240 VAC, 50/60 Hz.
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K Number
K971848Device Name
TDK MEDICAL GRADE CD-R
Manufacturer
TDK ELECTRONICS CORPORATION OF AMERICA
Date Cleared
1997-08-15
(88 days)
Product Code
LMB
Regulation Number
892.2010Why did this record match?
Product Code :
LMB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TDK Medical Grade CD-R is a storage medium used for picture archiving and exchange of recordable information. The TDK Medical Grade CD-R is a multisession disc with 650MB capacity, which is used in conjunction with cardio review stations and mini review stations that accept this type of media. TDK Medical Grade CD-R media provides the following capabilities; acquisition, exchange, display, review and archiving.
Device Description
The TDK Medical Grade CD-R is a storage medium used for picture archiving and exchange of recordable information. The TDK Medical Grade CD-R is a multisession disc with 650MB capacity, which is used in conjunction with cardio review stations and mini review stations that accept this type of media. TDK Medical Grade CD-R media provides the following capabilities; acquisition, exchange, display, review and archiving. The TDK Medical Grade CD-R conforms to ISO 9002, Orange Book, Part II.
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K Number
K971451Device Name
WISE IMAGE MANAGEMENT SYSTEM
Manufacturer
OTECH, INC.
Date Cleared
1997-06-26
(66 days)
Product Code
LMB
Regulation Number
892.2010Why did this record match?
Product Code :
LMB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SECTRA AB, WISE Image Management System device 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.
Device Description
WISE will be used for management of radiological images.
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K Number
K963936Device Name
ACCESSPOINT, MED E-MAIL, DICOM READER
Manufacturer
BIOSOUND, INC.
Date Cleared
1997-03-31
(181 days)
Product Code
LMB
Regulation Number
892.2010Why did this record match?
Product Code :
LMB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AccessPoint™ software is intended to translate different medical image formats into a single format suitable for display on a standard Personal Computer.
Device Description
Generally speaking, AccessPoint is a software product designed to provide the translation of different medical image formats into a form compatible to be displayed on a standard PC. Connection between sites including hospitals, out reach clinics, physician home and office are provided through the use of e-mail. The images and reports (patient studies) may be transported via e-mail in a secure manor (encryption of data) following standards used by the Internet and local LAN (Intranet), transport systems. A description of the various elements follow:
The AccessPoint™ software conforms to DICOM V3 service classes in the role of Service Class Reader.
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