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510(k) Data Aggregation
K Number
K021949Device Name
FULCRUM
Manufacturer
HOWTEK, INC.
Date Cleared
2002-08-12
(60 days)
Product Code
LMA
Regulation Number
892.2030Why did this record match?
Applicant Name (Manufacturer) :
HOWTEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Howtek Fulcrum Family consists of a transparency film digitizer and paper CCD scanner that is used to digitize radiographs or X-ray film as well as paper reports or doctor's orders. When the Fulcrum is used to digitize radiographic films, the digital image is intended for use in primary, secondary and over reading applications.
The Fulcrum Family does not include applications specific software (Picture Archiving and Communications (PAC) system, Teleradiology, or Computer Aided Detection (CAD) software). The manufacturer of the application software will determine specific indications for use. These third-party software packages or complete PAC systems are approved separately.
Device Description
The device is a transparency film digitizer and paper, charge coupled device (CCD) digitizer that can be used to digitize radiographs or paper reports. The digitizer reads digital gray scale information for each pixel deposits the raw data in the computer. The user interface for the digitizer resides in the applications software. There is no activate button on the digitizer. The activate button is provided trough the digitizer user interface which is part of the third party software package.
Overall the Fulcrum uses a drive, which transport the paper or film over the camera as it digitizes the image. Each scan line is captured by the chargecoupled device (CCD). The scan line of data is normalized and calibrated to align the response from each individual pixel. The image data signal is converted from analog to digital format by and A to D converter. The Fulcrum creates a digital image in either 16-bit, 12-bit or 8-bit raw format. The information is transmitted to the computer via USB II.
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K Number
K973081Device Name
DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)
Manufacturer
HOWTEK, INC.
Date Cleared
1997-11-05
(79 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
HOWTEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of DIGITIZER DIRECTOR: Image Compression Module is as a DICOM image compressor that will enable any hospital or medical facility PC with adequate memory and the appropriate film digitizer to send images to other DICOM entities such as viewing stations and databases in an efficient manner. The compression algorithms used are fully supported by the DICOM 3.0 Standard.
Device Description
DIGITIZER DIRECTOR: Image Compression Module is an expansion module to Digitizer Director. The module provides a compression solution which uses compression algorithms which are fully supported by DICOM. Digitizer Director is a DICOM 3.0 compliant secondary image capture application for the Howtek family of film digitizers, It is a query / retrieve service class provider (QRSCP). DIGITIZER DIRECTOR and the Image Compression Module are Microsoft Windows NT or Windows 95 based applications.
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K Number
K972191Device Name
DIGITIZER DIRECTOR (HSC025-01)
Manufacturer
HOWTEK, INC.
Date Cleared
1997-09-08
(90 days)
Product Code
LMD
Regulation Number
892.2020Why did this record match?
Applicant Name (Manufacturer) :
HOWTEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DIGITIZER DIRECTOR is a DICOM compatible software package which enables any medical facility personal computer (PC) with adequate memory and the appropriate film digitizer to perform secondary image capture of films using the Howtek film digitizer family. DIGITIZER DIRECTOR does not have any image compression capability. DIGITIZER DIRECTOR is an integrated DICOM network product which translates the images from proprietary digitizer format to DICOM format and sends them on to another DICOM application.
Device Description
DIGITIZER DIRECTOR is a DICOM 3.0 compliant secondary image capture application for the Howtek family of film digitizers, It is a query / retrieve service class provider (QRSCP). DIGITIZER DIRECTOR queries the designated DICOM 3.0 database as each patient record is created. Association is made with the patients already existing in the database. New patient information is required when no association is made. When patient information is complete, the entire patient record is sent to a designated DICOM entity, such as a database or viewing station. DIGITIZER DIRECTOR is a Microsoft Windows NT or Windows 95 based application.
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K Number
K970908Device Name
HOWTEK 960
Manufacturer
HOWTEK, INC.
Date Cleared
1997-05-20
(70 days)
Product Code
LMA
Regulation Number
892.2030Why did this record match?
Applicant Name (Manufacturer) :
HOWTEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is used in generating digital signals from medical radiographs. The digital signals are intended for use in PACS and tele-radiology.
Device Description
The device is a transparency, charge coupled device (CCD) scanner which can be used to digitize radiographs or X-ray film. The digitizer reads gray digital information from the image and sends the raw data file to a host computer, for use with a Picture Archiving and Communication (PAC) System or teleradiology software package currently in the market place as separately approved third party software packages or complete PAC system. The user interface for the film digitizer resides in the host application software program. The 960 creates a digital image file from transparent originals. The digital image file is expressed in either 8 or 12 bit grav level file format. The digitizer is connected to a host computer (either PC, Mac or UNIX) via SCSI II. There is no "activate" button the 960. To start an image capture operation, the user must activate the digitizer user interface on the host computer. Overall, The 960 uses a film fed drive which transports the film over the camera as it digitizes the image. Each scan line is captured by the charge coupled device (CCD). The scan line of data is normalized and calibrated to align the response from individual CCD receptors. The image data signal is converted from analog to digital format on the OCP board. The digital signal is then sent to the host via the SCSI II connection with the host computer.
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K Number
K953117Device Name
SCANMASTER DX
Manufacturer
HOWTEK, INC.
Date Cleared
1996-01-18
(199 days)
Product Code
LMA
Regulation Number
892.2030Why did this record match?
Applicant Name (Manufacturer) :
HOWTEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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