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510(k) Data Aggregation
K Number
K081557Device Name
PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER
Manufacturer
JDDB MANUFACTURING, INC
Date Cleared
2008-09-10
(99 days)
Product Code
IXA
Regulation Number
892.1850Why did this record match?
Product Code :
IXA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Portable Supine Patient Support and Cassette Holder is a supine support device intended to lay flat on a flat surface to hold and position a radiographis cassette, also to hold and position a patient for radiographic x-ray exposure. I intended for medical use.
Indications for Usessupine support intended to lay flat on a surface to i hold and position radiographic cassette, also to hold and position patient for radiographic exposure for medical use.
Device Description
The Portable Supine Patient Support and Cassette Holder is a portable, nonionizing radiation device used for scoliosis radiography of the spine. The device consists of a head support, a rectangular cassette holder (94cm×40.5cm), which will hold the cassette, a foot support, and a removable cover top on top of the cassette holder.
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K Number
K053173Device Name
DS CASSETTE
Manufacturer
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
Date Cleared
2005-12-15
(31 days)
Product Code
IXA
Regulation Number
892.1850Why did this record match?
Product Code :
IXA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DS Cassette is 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. It is not intended for mammography use.
Device Description
The DS Cassette is 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. The cassette is in a family of film sizes. The sizes are as follows; 35 x 43cm, 35 x 35cm, 40 x 40cm, 30 x 40cm, 30 x 35cm, 24 x 30cm, 24 x 24cm, 20 x 40cm, 18 x 43 cm, 18 x 24cm, 15 x 40cm, 15 x 30cm, 14 x 17inch, 14 x 14inch, 12 x 15inch, 11 x 14inch, 10 x 12inch, 8 x 10inch, 6.5 x 8.5inch, 7 x 17inch. The exposed film is taken out from the Cassette manually or automatically for processing by X-ray film processor such as Konica DS-7 automatic X-ray film processor, 510(k) number K931316.
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K Number
K040378Device Name
KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253
Manufacturer
EASTMAN KODAK COMPANY
Date Cleared
2004-05-24
(97 days)
Product Code
IXA
Regulation Number
892.1850Why did this record match?
Product Code :
IXA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KODAK DirectView CR cassette holds a storage phosphor screen which is exposed by radiographic equipment for the recording of a patient radiation pattern. The cassette is loaded into a compact laser scanner capable of reading the latent image. The Kodak DirectView CR 15 x 30 cm cassette and storage phosphor screen can be used for general radiology and dental panoramic radiography applications.
Device Description
The Kodak DirectView CR 15 x 30 cm cassette size is designed to perform general radiography and panoramic dental exams when used with the Kodak DirectView CR 850 and CR 950 systems. The cassette system (cassette and storage phosphor screen adhered to the cassette plate) can be used in common dental panoramic x-ray dental units designed to accept cassettes that meet the ISO 4090 standard. The CR cassette is a standard x-ray diagnostic cassette used for computed radiography. The panel materials are consistent with the current design of the CR cassette and include Corus Hylite and Toray Panel. The Corus Hylite panel includes two lavers of aluminum, with polypropylene (plastic) in the middle, and is covered with Omnova (clear viny) with printing on the second surface). On the tube side of the cassette there is Toray Carbon Fiber Panel that consists of four layers of carbon fiber. The storage phosphor plate is attached to the honeycomb panel. The lead mylar that is in place under the phosphor layer of the screen was removed in the CR 15 x 30 cm cassette in order to accommodate Automatic Exposure Control (AEC) in dental x-ray units.
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K Number
K023020Device Name
AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE
Manufacturer
AGFA CORP.
Date Cleared
2002-09-26
(15 days)
Product Code
IXA
Regulation Number
892.1850Why did this record match?
Product Code :
IXA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Agfa Film Cassettes are indicated 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 lightproof enclosure for direct exposure of radiographic film.
Device Description
There are three product lines of Agfa Film Cassettes covered by the present 510(k): (1) The Mamoray Mammography Cassettes, (2) the metal-bodied CAWO Cassettes, and (3) the ABS Plastic Curix and Lightweight Cassettes.
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K Number
K021903Device Name
KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE
Manufacturer
EASTMAN KODAK COMPANY
Date Cleared
2002-07-10
(30 days)
Product Code
IXA
Regulation Number
892.1850Why did this record match?
Product Code :
IXA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KODAK X-OMAT Cassette/Leadless for Dental Use is a light-tight holder for intensifying screen and film, keeping them in close contact to provide a good radiographic image. This cassette can be used with dental x-ray imaging equipment that has an automatic exposure control (AEC) device.
Device Description
Not Found
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K Number
K013686Device Name
KODAK DIRECTVIEW TABLETOP CASSETTE
Manufacturer
EASTMAN KODAK COMPANY
Date Cleared
2001-12-07
(30 days)
Product Code
IXA
Regulation Number
892.1850Why did this record match?
Product Code :
IXA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KODAK DirectView Tabletop CR Cassette holds a Storage Phosphor screen so the screen can be exposed by radiographic equipment for the recording of a patient radiation pattern. The screen is removed from the cassette and the pattern read in a laser phosphor digitizer.
Device Description
The device is a cassette for holding a storage phosphor screen. It is a standard x-ray diagnostic cassette used for film screen radiography that has been modified as follows. In place of the two intensifying screens two pieces of black polycarbonate sheet are mounted on the foam presently used in the X-Omat Cassette. The storage phosphor screens is constrained by the film pocket of the cassette and held in place by the two plastic sheets when the cassette is closed.
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K Number
K013229Device Name
LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE
Manufacturer
FERRANIA USA, INC.
Date Cleared
2001-10-12
(15 days)
Product Code
IXA
Regulation Number
892.1850Why did this record match?
Product Code :
IXA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ferrania LifeRay™ Mammo Cassettes are intended for use during mammography diagnostic 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.
Device Description
Ferrania LifeRay™ Mammo Cassettes are intended for use during mammography diagnostic 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 available in two sizes and two models. The LifeRay™ KW Mammo Cassettes contain a window that is compatible with Kodak ID Printers for marking film with patient identification data. The LifeRay™ FW Mammo Cassettes contain a window that is compatible with Ferrania ID Printers for the same purpose as before.
Both Ferrania LifeRay™ Mammo Cassettes and the predicate device 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.
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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?
Product Code :
IXA
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
K983918Device Name
RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)
Manufacturer
MASTEK, INC.
Date Cleared
1999-03-12
(128 days)
Product Code
IXA
Regulation Number
892.1850Why did this record match?
Product Code :
IXA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. The R-CLIP positions and secures limbs for radiographic x-ray exposure.
2. The R-CLIP provides vertical and horizontal limb positioning relative to plane of radiographic view.
3. The R-CLIP avoids x-ray exposure to surgical staff by eliminating the need to hold the limb during exposure.
4. The R-CLIP is reusable and autoclavable. The R-CLIP Retainer kit is sterile, single use only.
Device Description
Radiolucent Cassette LIMB Positioner (R-Clip)
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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?
Product Code :
IXA
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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