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MRCP+ v2 is a standalone software medical device. The purpose of the MRCP+ v2 device is to assist a trained operator with the quantitative evaluation of biliary system structures acquired from magnetic resonance (MR) images from a single time-point (a patient visit). A Perspectum-trained operator loads previously acquired magnetic resonance cholangiopancreatography (MRCP) data as input into the MRCP+ v2 device. A structured summary report is generated as output by the device, which includes quantitative analysis results and geometric characteristics of the biliary system and pancreatic ducts. The MRCP+ v2 report is intended to facilitate reporting by a radiologist for subsequent interpretation and to aid diagnosis by a physician as part of a panel of testing, including conventional radiological tools.
PERSPECTUM LTD
2.0.0
In Commercial Distribution
- B554MRCP2000 ()
- Radiology DICOM image processing application software
The Cydar EV software produces automated 3D overlays for use in endovascular surgery. The software detects vertebral anatomical information present in live X-ray images and matches ('registers') it to an existing CT scan of the patient in order to determine their precise position. This match then allows a 3D overlay to be generated in the correct position and projection. The Cydar EV software is hosted on cloud high-performance computers in order to accelerate performance
Cydar EV works with both flat panel detectors and image intensifiers on fixed and mobile X-ray sets. The Cydar EV Instructions for Use remain the same for all types of X-ray set.
Note: Federal law (US) restricts this device to sale by or on the order of a physician.
CYDAR LIMITED
EV-2
In Commercial Distribution
- 05060508110002 ()
- Angiographic x-ray system application software
The Piccolo® General Chemistry 6 , used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, gamma glutamyltransferase (GGT), glucose, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0006
In Commercial Distribution
- EABA40000061 ()
- EABA40000060 ()
400-0006
- Gamma-glutamyltransferase (GGT) IVD, reagent
- Alanine aminotransferase (ALT) IVD, reagent
- Urea IVD, reagent
- Creatinine IVD, reagent
- Glucose IVD, reagent
- Total aspartate aminotransferase (AST) IVD, reagent
Visaris Avanse® is a digital radiography imaging, control and management software (for imaging consoles) that works with DR flat panel detectors technology. Visaris Avanse® PACS provides functionality for digital radiography examinations from patient search and entry, generator control,image acquisition and processing to DICOM data archiving and export. Visaris Avanse® PACS can also include a number of Digital Radiology modules such as network DICOM archive (PACS module), DICOM modality worklist module and diagnostic workstation software to turn it into digital radiology department on a PC for small clinics. Visaris Avanse ® is autonomous software and involves no hardware. It runs under the MS Windows XP/7/8 operating system on any hardware platform meeting the minimum system requirements.
VISARIS DOO
Avanse DR
In Commercial Distribution
- 08606102809033 ()
- Radiological PACS software
The portable x-ray system, DHX-70H is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software.
And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
DigiMed Co., Ltd.
1
In Commercial Distribution
- 18800021800134 ()
- 08800021800137 ()
- 28800021800131 ()
- 38800021800138 ()
- 48800021800135 ()
- 58800021800132 ()
- 68800021800139 ()
- 78800021800136 ()
- 88800021800133 ()
- Diagnostic x-ray system generator, portable
The portable x-ray system, HYBRID Pro is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software.
And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
DigiMed Co., Ltd.
HYBRID Pro
In Commercial Distribution
- 18800021800127 ()
- 08800021800120 ()
- 28800021800124 ()
- 38800021800121 ()
- 48800021800128 ()
- 58800021800125 ()
- 68800021800122 ()
- 78800021800129 ()
- 88800021800126 ()
- Diagnostic x-ray system generator, portable
The portable x-ray system, HYBRID C70 is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software.
And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
DigiMed Co., Ltd.
HYBRID C70
In Commercial Distribution
- 18800021800110 ()
- 08800021800113 ()
- 28800021800117 ()
- 38800021800114 ()
- 48800021800111 ()
- 58800021800118 ()
- 68800021800115 ()
- 78800021800112 ()
- 88800021800119 ()
- Diagnostic x-ray system generator, portable
The portable x-ray system, HYBRID S70 is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software.
And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
DigiMed Co., Ltd.
1
In Commercial Distribution
- 18800021800103 ()
- 08800021800106 ()
- 28800021800100 ()
- 38800021800107 ()
- 48800021800104 ()
- 58800021800101 ()
- 68800021800108 ()
- 78800021800105 ()
- 88800021800102 ()
- Diagnostic x-ray system generator, portable
The portable x-ray system, BIOX is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software.
And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
DigiMed Co., Ltd.
1
In Commercial Distribution
- 18800021800042 ()
- 08800021800045 ()
- 28800021800049 ()
- 38800021800046 ()
- 48800021800043 ()
- 58800021800040 ()
- 68800021800047 ()
- 78800021800044 ()
- 88800021800041 ()
- Diagnostic x-ray system generator, portable
The ophthalmic YAG laser system YC-1800 emits Nd: YAG laser (hereafter called “YAG laser”) pulse beam by Q-switching. The YC-1800 allows the safe and bloodless treatment of intraocular diseases for outpatients by mechanical disruption caused by energy of the YAG laser pulses. The main purposes
of the YC-1800 are posterior capsulotomy for secondary cataract, iridotomy for acute angle-closure glaucoma, and for pupillary membranectomy for traction retinal detachment. The YC-1800 has a slit lamp for observation that includes the YAG laser and its controlling mechanism. The YC-1800 is also equipped with an operation panel and knobs that facilitate operation. The compact and lightweight power supply box is installed separately for lightness and compactness of the system. In addition, a motorized table for the YC-1800 is available optionally.
NIDEK CO.,LTD.
YC-1800
In Commercial Distribution
- 04987669100073 ()
- Ophthalmic solid-state laser system, photodisruption