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The Precision CRF is a multi-functional general Radiography/ Fluoroscopy (R/F) system and includes
• Footrest
• Hand Grips
Radiation Protection Accessories
• Flexible Radiation Protection Apron
• Front Radiation Protection Apron
Additional Accessories (Optional)
• Monitor Trolley
• Monitor Ceiling Suspension
• Parking Frame for Accessories
• Shoulder Support
• Side bar
• Compression Belt
• Adjustable Lateral Cassette Holder
• Leg Supports
• Infusion Bottle Holder
• Arm Support for Catheterization
• Ankle Clamps
• Overhead Hand Grip
• Adult Headrest
• Mattress
• Rotatable Stool for Footrest
• Pediatric Micturition Set
• Stretch Grip for Wall Stand
• Bar Code Scanner
• Patient Support
• Stitching Ruler
Accessories for the SkyPlate Detector (Optional)
• Mobile Detector Holder
• Detector Holder Patient Bed
• Portable Panel Protector
• Detector Handle
• WPD Bags
• Grids for SkyPlate Detector large
Philips Medical Systems DMC GmbH
706400
In Commercial Distribution
- 00884838110588 ()
- Stationary general-purpose fluoroscopic x-ray system, digital
The ProxiDiagnost N90 is a multi-functional general Radiography/ Fluoroscopy (R/F) system and includes
• Footrest
• Hand Grips
Radiation Protection Accessories
• Flexible Radiation Protection Apron
• Front Radiation Protection Apron
Additional Accessories (Optional)
• Monitor Trolley
• Monitor Ceiling Suspension
• Parking Frame for Accessories
• Shoulder Support
• Side bar
• Compression Belt
• Adjustable Lateral Cassette Holder
• Leg Supports
• Infusion Bottle Holder
• Arm Support for Catheterization
• Ankle Clamps
• Overhead Hand Grip
• Adult Headrest
• Mattress
• Rotatable Stool for Footrest
• Pediatric Micturition Set
• Stretch Grip for Wall Stand
• Bar Code Scanner
• Patient Support
• Stitching Ruler
Accessories for the SkyPlate Detector (Optional)
• Mobile Detector Holder
• Detector Holder Patient Bed
• Portable Panel Protector
• Detector Handle
• WPD Bags
• Grids for SkyPlate Detector large
Philips Medical Systems DMC GmbH
706110
In Commercial Distribution
- 00884838103221 ()
- Stationary general-purpose fluoroscopic x-ray system, digital
The Piccolo® Kidney Check , used with the Piccolo Xpress chemistry analyzer, is intended to be used for the in vitro quantitative determination of creatinine 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.
400-0033
In Commercial Distribution
- EABA40000331 ()
- EABA40000330 ()
400-0033
- Urea IVD, reagent
- Creatinine IVD, reagent
MOCACuff (HL168KF) uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being’s wrist. All values can be read out in one LD panel. The device is designed for home use and recommended for use by adults aged 18 years and older with wrist circumference ranging approx. 5.3~7.7 inch.
The user is able to set the personal target value and the device will flash the value when the measured blood pressure value exceeds the target one. Further, HL168KF feature a built-in Bluetooth Data Transmission function, which enables the device automatically transmit measuring results to paired Bluetooth device after measurement.
MOCACARE CORP.
White (HL168KF)
In Commercial Distribution
- 00850842006063 ()
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
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 IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Centerline Biomedical, Inc.
SW-1
In Commercial Distribution
- 00843152104000 ()
SW-1
- Electromagnetic surgical navigation device tracking system
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Centerline Biomedical, Inc.
MC-1
In Commercial Distribution
- 00843152100002 ()
MC-1
- Electromagnetic surgical navigation device tracking system
UNIT CART PREMIUM-ELEC. 100-120VAC Universal device cart with reinforced bridge for mounting swivel arms, incl. rear panel and integrated cable duct. 3 shelf units (width 370 mm), 2 of which continuously adjustable. 4 double casters, 2 of which with dual-function locking (directional locking/freewheeling/full locking), 2 electrically conductive casters. Interfaces for mounting swivel arms and attaching comprehensive accessories. color: white, RAL 9016, side profiles made of aluminum. dimensions (WxHxD): 720 x 1,518 x 700 mm. Cart including PREMIUM ELECTRICS 100-120V, consisting of: basic housing (premium version) with integrated isolating transformer 100- 120V, insulation monitoring unit and shutdown module, socket strip with main switch module, insulation monitor display and 12 sockets, 6 device connection cables.
Richard Wolf GmbH
32116013
In Commercial Distribution
- 04055207025024 ()
32116013
- Medical device integration rack
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
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