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Found 8 results
510(k) Data Aggregation
K Number
K000412Device Name
VISION R/F TILTING TABLE
Manufacturer
VILLA SISTEMI MEDICALI S.P.A.
Date Cleared
2000-04-24
(76 days)
Product Code
IXR
Regulation Number
892.1980Why did this record match?
Product Code :
IXR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K973039Device Name
LEGACY/LEGACY-D TABLE
Manufacturer
GE MEDICAL SYSTEMS
Date Cleared
1997-10-16
(63 days)
Product Code
IXR
Regulation Number
892.1980Why did this record match?
Product Code :
IXR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This table is intended for use in a diagnostic x-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions.
Device Description
The Legacy/Legacy-D table is a patient support providing angulation to +/- 90 degrees and tabletop motion in the longitudinal and lateral directions. It includes an integrated table bucky and a spot film/fluoroscopic tower. The new bucky has the same function as the older version.
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K Number
K971128Device Name
CAP-35B III/CINE 275
Manufacturer
JAMIESON FILM CO.
Date Cleared
1997-04-28
(32 days)
Product Code
IXR
Regulation Number
892.1980Why did this record match?
Product Code :
IXR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CAP-35BIII and the CINE 275 are intended to view 35 mm cineangiogram film.
Device Description
The CAP-35BII cineangiogram projector is a continuous film transport 16-facet rotating prism projectors. The CINE 275 is a simpler version of the CAP-35BIII, with fewer options. The CAP-35BIII consists of a 35 mm film projector with built-in viewing hood, a movable cart, a sheet film duplicator, a 35 mm slide camera, a remote control, and an optional TV camera assembly. The CINE 275 consists of a 35 mm film projector with built-in viewing hood and a movable cart.
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K Number
K970640Device Name
PHILIPS EASY DIAGNOST
Manufacturer
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
Date Cleared
1997-03-21
(29 days)
Product Code
IXR
Regulation Number
892.1980Why did this record match?
Product Code :
IXR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Philips EasyDIAGNOST is the same as for the Philips DIAGNOST 76 plus.
Device Description
The Philips EasyDIAGNOST is a multi-functional R/F system consisting of a floormounted tilting patient support table and a spotfilm device holding an image intensifier and the TV camera. The tabletop can be moved by motor in longitudinal and lateral directions. The spot film device tilts with the table, and can be moved in three directions, relative to the table and to the patient. As a fully integrated system, it can be configured with generators from the Philips Medio, Super CP, and OPTIMUS families, with digital spot film cameras from the Philips DSI family, and with a Philips EASY VISION workstation. The system comes with a trimode Image Intensifier, XTV imaging system, Philips glass or metal X-ray tube(s), and TV monitor(s). An optional dedicated ultrasound system (Scanner 200X) can also be added.
The system can also be extended with an overtable tube which operates on a bucky tray inside the table and/or on a bucky wallstand (so-called second plane). This second plane option is identical to a Philips bucky DIAGNOST system, except for the table itself.
Philips Grid Controlled Fluoroscopy (GCF) can be provided using an SRM (metal) gridswitched X-ray tube. GCF improves overall image quality and provides dose reduction through precise control of fluoroscopic pulse shapes, eliminating excess radiation associated with pulse ramping and trailing effects of conventional pulsed fluoroscopy.
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K Number
K965105Device Name
ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
Manufacturer
U.S. IMAGING TABLES, INC.
Date Cleared
1997-01-30
(41 days)
Product Code
IXR
Regulation Number
892.1980Why did this record match?
Product Code :
IXR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
to position patients for a dia procedure employing some imaging technique or to position a patient for various treatments in or hospitals.
Device Description
the Electrophysiology 40 Tilt Table (Model 9660) and the Delux Model 9660 are designed for clinical applications such as: to position patients for a dia procedure employing some imaging technique or to position a patient for various treatments in or hospitals. This device is used by a physician or a health care professional; this device is not operated by a patient. This is a Class II device. As such this device has a Classification name as: Mobile Fluoroscopic Tilting Table, as described in 21 CFR Part 892. 11980. U.S. Imaging Tables, Incorporated has determined this device is substantially equivalent to a predicate medical device which is currently in commerce and is identified as: Deluxe "C" Arm Stretcher, Model 056-004, and is manufactured by Biodex Medical Systems, Inc. of Shirley New York.
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K Number
K965096Device Name
FLUOROVIEW SERIES FLUOROSCOPIC TABLES
Manufacturer
U.S. IMAGING TABLES, INC.
Date Cleared
1997-01-27
(38 days)
Product Code
IXR
Regulation Number
892.1980Why did this record match?
Product Code :
IXR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
to support a patient and facilitate a diagnostic procedure employing some imaging technique or to position a patient for various treatments in clinics or hospitals.
Device Description
This device, the Fluoroview "" Series Fluoroscopic Tables (Model 9680) and the Time Table C-Arm Stretcher. Model 9670 is designed for clinical applications such as: to support a patient and facilitate a diagnostic procedure employing some imaging technique or to position a patient for various treatments in clinics or hospitals. This device is used by a physician or a health care professional: this device is not operated by a patient. This is a Class II device has a Classification name as: Mobile Fluoroscopic Tilting Table, as described in 21 CFR Part 892.11980. U.S. Imaging Tables, Incorporated has determined this device is substantially equivalent to a predicate medical device which is currently in commerce and is identified as: Deluxe "C" Arm Stretcher, Model 056-004. and is manufactured by Biodex Medical Systems. Inc. of Shirley New York.
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K Number
K963851Device Name
TILTING RADIOGRAPHIC TABLE (REMOTE)
Manufacturer
ACOMA MEDICAL IMAGING, INC.
Date Cleared
1997-01-23
(120 days)
Product Code
IXR
Regulation Number
892.1980Why did this record match?
Product Code :
IXR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961022Device Name
TANGENT VI TABLE
Manufacturer
FISCHER IMAGING CORP.
Date Cleared
1996-05-03
(50 days)
Product Code
IXR
Regulation Number
892.1980Why did this record match?
Product Code :
IXR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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