Search Results
Found 6 results
510(k) Data Aggregation
K Number
K992229Device Name
MXU-125 OR TMX-125
Manufacturer
Date Cleared
1999-08-06
(35 days)
Product Code
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
TREX MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MXU-125 or TMX-125 is a Mobile x-ray Unit intended for use in general radiographic medical procedures by a licensed professional.
Device Description
The Mobile X-ray Unit is a portable, battery-powered, self-propelled - unit - designed - for - making - film radiographs in a hospital environment. The unit is capable of generating diagnostic x-rays according to the technique factor combinations selected and controlled by the operator.
Ask a Question
Ask a specific question about this device
K Number
K984091Device Name
CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000
Manufacturer
Date Cleared
1999-02-05
(81 days)
Product Code
Regulation Number
892.1710Why did this record match?
Applicant Name (Manufacturer) :
TREX MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Contour 2000 Mammography system, Model CTR-2000, is used for dedicated mammographic examination
Device Description
The Bennett Contour 2000 Mammographic System, Model CTR-1. 2000, is a dedicated mammographic imaging system used as an x-ray source in the performance of mammographic examinations. The CTR-2000 is adaptable to performing screening and/or biopsy procedures with the addition of either a film-based or digital-based image receptor device attached. It consists of the following components; an x-ray generator cabinet, Model M-2000G (single-phase input) or Model M-2000G-3P (three-phase input); a tube stand with a tilting c-arm; mammographic collimator (DM-2000) and tube; an operator control panel, Model M-2000C; and image receptor (film cassette holder or bucky).
The Contour 2000 Mammography System is a microprocessor-controlled x-ray source requiring single-phase 200-240 VAC, 50/60 Hz or three-phase 208-440 VAC, 50/60 Hz for operation. The Contour 2000 system's c-arm is fully counterbalanced and is locked in position using electro-mechanical locks. The c-arm has a fixed source-to-image distance (SID) of 76 cm.
Ask a Question
Ask a specific question about this device
K Number
K984092Device Name
PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000
Manufacturer
Date Cleared
1999-02-05
(81 days)
Product Code
Regulation Number
892.1710Why did this record match?
Applicant Name (Manufacturer) :
TREX MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
THE PROFILE 2000 MAMMOGRAPHY SysTEM, MODEL PRO-2000, 15 A DEDICATED MANMOGRAPHIC IMAGING SysTEM USED FOR MAMMOGRAPHIC EXAMINATIONS.
Device Description
The Bennett Profile 2000 Mammographic System, Model PRO-1. 2000, is a dedicated mammographic imaging system used as an x-ray source in the performance of mammographic examinations. The PRO-2000 is adaptable to performing screening and/or biopsy procedures with the addition of either a film-based or digital-based image receptor device attached. It consists of the following components; an x-ray generator cabinet, Model M-2000G (single-phase input) or Model M-2000G-3P (three-phase input); a tube stand with a non-tilting c-arm; mammographic collimator (DM-2000) and tube; an operator control panel, Model M-2000C; and image receptor (film cassette holder or bucky).
The Profile 2000 Mammography System is a microprocessor-controlled x-ray source requiring single-phase 200-240 VAC, 50/60 Hz or three-phase 208-440 VAC, 50/60 Hz for operation. The Profile 2000 system's c-arm is fully counterbalanced and is locked in position using electro-mechanical locks. The c-arm has a fixed source-to-image distance (SID) of 76 cm.
Ask a Question
Ask a specific question about this device
K Number
K984414Device Name
XRE COLLIMATOR WITH SPECTRAL FILTER
Manufacturer
Date Cleared
1998-12-30
(20 days)
Product Code
Regulation Number
892.1610Why did this record match?
Applicant Name (Manufacturer) :
TREX MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The XRE Collimator with spectral filter is designed to be the primary X-ray beam limiting device as part of an angiographic imaging system and is controllable manually and automatically. It also provides a means of manual or automatic selection of filtration designed to reduce the xray dose applied to the patient while still providing high quality images. It is designed to be operated by professional medical personnel only.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
K Number
K982427Device Name
TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C
Manufacturer
Date Cleared
1998-09-23
(72 days)
Product Code
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
TREX MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TREX Tilt-C, Integrated C-Arm/Table multipurpose radiographic/fluoroscopic positioning system. It is an all-digital multi-purpose system designed to address a broad variety of radiographic/fluoroscopic, interventional and limited angiographic procedures.
Device Description
Integrated C-Arm/Table multipurpose radiographic/fluoroscopic positioning system, Model TREX Tilt-C. It is an all-digital multi-purpose system designed to address a broad variety of radiographic/fluoroscopic, interventional and limited angiographic procedures.
Ask a Question
Ask a specific question about this device
K Number
K982120Device Name
DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY)
Manufacturer
Date Cleared
1998-09-10
(86 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
TREX MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Digital Imaging System, Model DigiTREX-X000 is a digital video processing system and is intended to be produced by the radiographic, fluoroscopic, or special procedure systems, excluding mamography.
Device Description
Digital Imaging System, Model DigiTrex-1000 and DigiTrex-2000 is a digital video processing system.
Ask a Question
Ask a specific question about this device
Page 1 of 1