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Found 5 results
510(k) Data Aggregation
K Number
K984252Device Name
IMATION TRIMATIC DIGITAL SYSTEM
Manufacturer
IMATION CORP.
Date Cleared
1999-01-25
(59 days)
Product Code
LMA
Regulation Number
892.2030Why did this record match?
Applicant Name (Manufacturer) :
IMATION CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Imation™ Trimatic™ Digital System is intended for use an automated system to convert radiographic films into a DICOM format image for use in a hospital or other clinical Image Management System(IMS). The digitizer has the resolution capable of faithfully digitizing standard and mammographic x-ray films.
Device Description
The Imation™ Trimatic™ Digital System is intended for use as a system to convert radiographic films into a digitized format for use in a hospital or other clinical image management system. The digitized image receives patient and exam information and is then forwarded into a DICOM compliant image management system. The digitizer has the resolution capable of faithfully digitizing standard and mammographic x-rays.
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K Number
K980722Device Name
TRIMAX RADIOGRAPHIC CASSETTE
Manufacturer
IMATION CORP.
Date Cleared
1998-03-23
(27 days)
Product Code
IXA
Regulation Number
892.1850Why did this record match?
Applicant Name (Manufacturer) :
IMATION CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Imation Trimax Cassettes are intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.
Device Description
Imation Trimax Cassettes are intended for use during diagnostic x-ray procedures to hold radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film. The cassettes are in a family of film sizes. The Trimax C-1 series contain a window that permits writing by a radiographic film marking system. The Trimax C-2 series is windowless.
Radiologic cassettes are comprised of a light-tight chamber for preventing radiologic film exposure, a compressible backplate material to assure intimate film screen contact, a latching mechanism for removal and replacement of radiographic film, a patientoriented surface transparent to x-ray energy, lead shielding to prevent unwanted exposure to stray x-ray energy and suitable support structure for durability of the assembly.
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K Number
K973303Device Name
IMATION MODEL 9410 NETWORK INTERFACE
Manufacturer
IMATION CORP.
Date Cleared
1997-11-25
(83 days)
Product Code
LMD
Regulation Number
892.2020Why did this record match?
Applicant Name (Manufacturer) :
IMATION CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Imation™ MODEL 9410 NETWORK INTERFACE Network Interface is intended for use as a communications gateway. It accepts input from imaging source modalities and transfers the image data to a compatible printing, viewing, archive or network system. The MODEL 9410 NETWORK INTERFACE accepts input in DICOM standard, digital or video formats and converts, if needed, to DICOM Standard or other digital formats. The system is intended for use with a variety of imaging modalities including CT, MR and CR for the transmission of image data to a variety of printing, viewing and storage devices.
Device Description
The Imation™ MODEL 9410 NETWORK INTERFACE Network Interface is intended for use as a communications gateway. It accepts input from imaging source modalities and transfers the image data to a compatible printing, viewing, archive or network system. The MODEL 9410 NETWORK INTERFACE accepts input in DICOM standard, digital or video formats and converts, if needed, to DICOM Standard or other digital formats. The system is intended for use with a variety of imaging modalities including CT, MR and CR for the transmission of image data to a variety of printing, viewing and storage devices.
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K Number
K972163Device Name
IMATION SE-196 LASER IMAGER
Manufacturer
IMATION CORP.
Date Cleared
1997-09-05
(88 days)
Product Code
LMC
Regulation Number
892.2040Why did this record match?
Applicant Name (Manufacturer) :
IMATION CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Imation™ SE-196 laser imager is intended use as a high quality hard copy device for output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the SE-196 and transformed optically to expose Imation imaging media. The system is intended for use with a variety of digital modalities including CT, MR and CR for diagnostic use by medical radiologists and communications to referring physicians and their patients.
Device Description
The Imation SE-196 Laser Imager provides high quality hard copy film output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the SE-196 and transformed optically to expose Imation imaging media. The system is intended for use with a variety of digital modalities including CT, MR and CR for diagnostic use by medical radiologists and communications to referring physicians and their patients.
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K Number
K962750Device Name
3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR
Manufacturer
IMATION CORP.
Date Cleared
1996-08-21
(37 days)
Product Code
IXW
Regulation Number
892.1900Why did this record match?
Applicant Name (Manufacturer) :
IMATION CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3M Trimatic™ Modular Advanced Processing System is an automatic, modular system for unloading exposed x-ray film from x-ray film cassettes, processing the film, and reloading the empty x-ray film cassette with fresh x-ray film of the same size and type. This system is used for handling and processing of x-ray films from all general radiographic, diagnostic procedures which employ conventional x-ray film / screen technology. The integrated automatic x-ray film processor can also be used as a stand-alone processor.
Device Description
The 3M Trimatic™ Modular Advanced Processing System is an automatic, modular system for unloading exposed x-ray film from x-ray film cassettes, processing the film, and reloading the empty x-ray film cassette with fresh x-ray film of the same size and type. The 3M Trimatic™ Modular APS will accommodate from four to seven different film types / sizes in film modules. The integrated automatic x-ray film processor in the subject device uses mechanical rollers and guides, chemical replenishment and chemical agitation methods. The software used to control the operation of the subject device has added capabilities over the software used in the predicate device. Encoded in the bar codes on the x-ray film cassettes are the x-ray film size, type and the correct processing conditions for that particular film. This information drives the operation of the device. Remote diagnostics via phone line is also an added feature in the subject device. The control panel controls both the load / unload process and the automatic x-ray film processor.
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