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Found 3 results
510(k) Data Aggregation
K Number
K013395Device Name
LIFEJET VIDEO LINK
Manufacturer
FERRANIA S.P.A.
Date Cleared
2001-10-30
(15 days)
Product Code
LMA
Regulation Number
892.2030Why did this record match?
Applicant Name (Manufacturer) :
FERRANIA S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LifeJet™ Video Link is a video image digitizer for the acquisition and conversion into digital format of medical images codified as analogue video signal.
The LifeJet™ Video Link has been developed to be used together with LifeJet™ Printers to produce referral prints of images coming out from ultrasound systems or other medical equipment through the video signal output.
Device Description
The LifeJet™ Video Link is a small box that integrates the functions and the hardware of a standard personal computer based on a Pentium architecture, for the purpose of acquisition and conversion into digital format of medical images codified as analogue video signal.
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K Number
K012373Device Name
LIFERAY WL CASSETTE, LIFERAY KW CASSETTE
Manufacturer
FERRANIA S.P.A.
Date Cleared
2001-08-09
(14 days)
Product Code
IXA
Regulation Number
892.1850Why did this record match?
Applicant Name (Manufacturer) :
FERRANIA S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ferrania LifeRay™ Cassettes are intended for use during diagnostic X-ray procedures to provide a light-proof enclosure for direct exposure of radiographic film and to hold this radiographic film in close contact with an X-ray intensifying screen.
Device Description
Ferrania LifeRay™ 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 this film. The Cassettes are in a family of film sizes. The LifeRay™ KW Cassettes contain a window compatible with Kodak system, that permits data writing by a radiographic film marking system. The LifeRay™ WL Cassette is windowless. Radiographic cassettes are composed of: a light tight chamber for preventing radiographic film exposure, a compressible backplate material to assure intimate film-screen contact, a latching mechanism for removal and replacement of radiographic film, a patient oriented surface transparent to x-ray energy, lead shielding to prevent unwanted exposure to x-rays assembled in a robust support structure to assure durability.
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K Number
K011617Device Name
LIFEJET PRINTER 400
Manufacturer
FERRANIA S.P.A. STABILIMENTO DI FERRANIA
Date Cleared
2001-06-08
(14 days)
Product Code
LMC
Regulation Number
892.2040Why did this record match?
Applicant Name (Manufacturer) :
FERRANIA S.P.A. STABILIMENTO DI FERRANIA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LifeJet™ Printer 400 is an ink jet printer designed to provide referral high quality color and/or gray scale hard copies of medical images generated by medical equipment. The LifeJet™ Printer 400 has been developed to be used together with LifeJet™ Medical Paper and LifeJet™ Medical Ink Jet Cartridges to achieve the best quality medical images.
Device Description
The LifeJet™ Printer 400 is an inkjet printer designed to produce high quality color and gray-scale referral medical images. Together with specifically designed medical paper and inks (LifeJet™ Medical Paper and LifeJet™ Medical Ink Jet Cartridges) the LifeJet™ Printer 400 forms the LifeJet™ 400 System, which is an innovative, convenient and work-flow improving medical printing platform, based on the state of the art inkjet technology, capable of delivering superior and reliable printed images for any medical documentation requirement.
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