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Toshiba Receives FDA Clearance For Multi-purpose Digital X-ray System.


TUSTIN, Calif.--(BUSINESS WIRE)--Jan. 10, 1996--Toshiba America Medical Systems (TAMS) Inc., Wednesday announced it has received FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 clearance to market its multi-purpose all digital R&F X-ray diagnostic imaging system -- the MAX-1000A.

By integrating a C-arm positioner with a tilting table, Toshiba offers an X-ray system with the ability to perform diagnostic radiographic and fluoroscopic Fluoroscopic (fluoroscopy)
An x-ray procedure that produces immediate images and motion on a screen. The images look like those seen at airport baggage security stations.

Mentioned in: Hypotonic Duodenography
, non-vascular interventional and general angiographic procedures.

"The MAX-1000A is ideal for institutions concerned about obtaining the highest level of productivity possible for their capital investment," said Don Volz, director, X-ray Business Unit. "Yielding the value of multiple systems in one, this R&F X-ray unit can be used as a primary imaging system or as a supplement to existing equipment."

The MAX-1000A accommodates double-contrast GI/BE, myelography Myelography Definition

Myelography is an x-ray examination of the spinal canal. A contrast agent is injected through a needle into the space around the spinal cord to display the spinal cord, spinal canal, and nerve roots on an x ray.
, hysterosalpingography, arthrography Arthrography Definition

Arthrograpy is a procedure involving multiple x rays of a joint using a fluoroscope, or a special piece of x-ray equipment which shows an immediate x-ray image.
, percutaneous cholangiography cholangiography /cho·lan·gi·og·ra·phy/ (kol-an?je-og´rah-fe) radiography of the bile ducts.

cho·lan·gi·og·ra·phy
n.
 and endoscopic retrograde cannulation can·nu·la·tion or can·nu·li·za·tion
n.
Insertion of a cannula.



cannulation

introduction of a cannula into a tubelike organ or body cavity.
 R&F applications. In non-vascular intervention, procedures include stone removal, tube placements, abscess drainage, hepatic and renal shunts, balloon angioplasty and biopsies. Interventional radiology procedures include transjugular interhepatic portal to system shunt, filter placement and abdominal angiography.

The C-arm allows left and right cross-lateral positioning and dual anterior/posterior and posterior/anterior functionality. The X-ray table rotates 360 degrees and tilts 90/90 degrees.

The 1024 CCD CCD
 in full charge-coupled device

Semiconductor device in which the individual semiconductor components are connected so that the electrical charge at the output of one device provides the input to the next device.
 digital camera, with 1,000,000 pixel resolution, and the 16-inch Super Metal Image Intensifier ensure maximum image quality and greater diagnostic capabilities. The MAX-1000A is combined with the award-winning EPS-30 electronic photo-spot angiographic device to provide features which include DSA, subtracted roadmapping, pixel shifting, zoom and relative stenosis measurement.

The system's digital capabilities help speed X-ray image processing resulting in less radiation exposure to the patient, accelerated throughput as well as the ability to identify minute images like polyps, vessels and catheter tips.

Remote control operation of the MAX-1000A accelerates procedures and reduces radiation exposure for radiologists. Using the side-by remote tableside gives the radiologist easy control of collimation collimation /col·li·ma·tion/ (kol?i-ma´shun)
1. in microscopy, the process of making light rays parallel; the adjustment or aligning of optical axes.

2.
, C-arm movement, fluoro exposure and digital image review. Also, the MAX-1000A includes automated abdominal compression which saves time and promotes the flow of contrast media without the radiologist's or technician's in-room intervention.

Other clinical-enhancing features include a pulsed progressive fluoroscopy fluoroscopy /flu·o·ros·co·py/ (fldbobr-ros´kah-pe) examination by means of the fluoroscope.

fluo·ros·co·py
n.
Examination by means of a fluoroscope. Also called radioscopy.
 option and high-frequency inverter generator.

"In the continual drive to provide better patient care while decreasing costs, this new system offers excellent image quality, helps realize dose and cost savings and increases throughput," said Volz. "The greater utilization afforded by a multi-purpose system is a good investment for smaller institutions with lower procedural volumes."

Toshiba America Medical Systems, Inc., with headquarters in Tustin, Calif., markets, sells, distributes and services diagnostic imaging systems. In addition to X-ray, Toshiba's imaging products include CT (computed tomography), MRI (magnetic resonance imaging magnetic resonance imaging (MRI), noninvasive diagnostic technique that uses nuclear magnetic resonance to produce cross-sectional images of organs and other internal body structures. ), nuclear medicine and ultrasound. Toshiba America MRI, Inc., is a subsidiary of TAMS and has responsibility for research and development, engineering and manufacturing in the United States.

CONTACT: Toshiba America Medical Systems, Tustin, Calif.

Catherine M. Eilts, 714/669-4140
COPYRIGHT 1996 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1996, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Jan 10, 1996
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