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TRAQinform Reports is a 100% software medical device data system that provides users with the means to select, render and modify layouts of static and interactive reports. TRAQinform Reports does not perform any image analysis or image processing of medical images. The device provides features to render available data components to formatted PDF, web pages, or text files.
Aiq Global, Inc.
1
In Commercial Distribution
- 00860007104947 ()
- Radiology information system application software
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Adult and pediatric interpretation; Software kit; US/Canada power cord; No printer; ECG clip adapters (set of 10) and tab electrodes (pouch of 100); AHA 10 wire, 12-lead lead set with banana plugs; Advanced connectivity-includes DICOM order and output and XML order and XML/PDF output
WELCH ALLYN, INC.
901127
In Commercial Distribution
- 00732094263169 ()
RSCRIBE-6AC-AXDBB
- Electrocardiograph, professional, multichannel
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; Snap adapters (set of 10) and monitoring electrodes (pouch of 10); AHA 10 wire, 12-lead lead set with banana plugs; Advanced connectivity-includes DICOM order and output and XML order and XML/PDF output
WELCH ALLYN, INC.
901127
In Commercial Distribution
- 00732094263138 ()
RSCRIBE-6AC-XXBAB
- Electrocardiograph, professional, multichannel
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; AM12 Wired Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; Snap adapters (set of 10) and monitoring electrodes (pouch of 10); AHA 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution
- 00732094263084 ()
RSCRIBE-6CC-XXBAA
- Electrocardiograph, professional, multichannel
RScribe 12-Lead Multi-Channel Electrocardiograph - version 7, current software CD; WAM Wireless Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; ECG clip adapters (set of 10) and tab electrodes (pouch of 100); IEC 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
Not in Commercial Distribution
- 00732094262964 ()
RSCRIBE-7AC-XXABA
- Electrocardiograph, professional, multichannel
RScribe 12-Lead Multi-Channel Electrocardiograph - version 7, current software CD; WAM Wireless Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; ECG clip adapters (set of 10) and tab electrodes (pouch of 100); IEC 10 wire, 12-lead lead set with banana plugs; Advanced connectivity-includes DICOM order and output and XML order and XML/PDF output
WELCH ALLYN, INC.
901127
Not in Commercial Distribution
- 00732094262957 ()
RSCRIBE-7AC-XXABB
- Electrocardiograph, professional, multichannel
CHECKLIST APP This app requires core.portal. The checklist app is a universal questionnaire and checklist system for collecting information during surgery. Checklists can be defined as customer-specific multilingual templates. The checklists are displayed in accordance with the language selected in the core.browser. The app generates a PDF report with the demographic patient data, information about the surgical intervention, a logo and the recorded data. The report is part of the documentation. The app does not spread the information collected.
Richard Wolf GmbH
5597706
Not in Commercial Distribution
- 04055207070086 ()
5597706
- Operating room audiovisual data/device management system application software
Imbio’s Coronary Artery Calcification (CAC) software is a set of automated image post-processing algorithms designed to help radiologists and cardiologists determine the location and calculate the amount of calcification within the coronary arteries in patients who have undergone a non- contrast, chest computed tomography (CT), by providing visualization and quantification of abnormal coronary CT densities. The Imbio CAC software runs automatically on the input CT series, with no user input or intervention.
The Imbio CAC software analyses high resolution CT DICOM images of the heart.
The Imbio CAC algorithm provides a DICOM or PDF summary report with the results of the analysis.
Imbio, LLC
2.0.0
In Commercial Distribution
- 00850894007797 ()
- Radiology DICOM image processing application software
CUBEScan BioCon-900 (bladder volume measurement system) is a safe and easy, noninvasive system to measure the bladder volume. CUBEScan BioCon-900 is a B-mode instrument, hand-held, wireless and battery-operated. A 3D-mechnical sector transducer provides cross-sectional images of the bladder from up to 12 scan planes and bladder volume is calculated based upon those images and displays 12 scan planes on a screen. Furthermore,
a live image of the bladder during Pre-scan makes it easier to detect the bladder before scanning. Measurements are transmitted to a personal computer running CubePro software via a wireless connection. CubePro allows the user to input the patient information, print measurements, export to pdf or jpg, archive data, and review data.
Mcube Technology Co., Ltd.
BioCon-900
In Commercial Distribution
- 08809458500009 ()
- Bladder volume ultrasound imaging system
The On-X® Prosthetic Heart Valve is a bileaflet mechanical heart valve, which consists of an orifice housing and two leaflets. The orifice inflow area has a flared inlet designed to reduce flow turbulence, and the outflow rim consists of leaflet guards designed to protect the leaflets while in the closed position. The leaflets rotate around tabs located within the inner circumference of the orifice ring. In the closed position, each leaflet forms a nominal angle of 40º relative to the plane of the orifice. In the open position, the plane of each leaflet forms a nominal angle of 90deg relative to the plane of the orifice. The leaflets have a travel arc of 50deg to the closed position.
The orifice, or housing, is composed of a graphite substrate coated with On-X® Carbon, a pure unalloyed form of pyrolytic carbon. The leaflets consist of On-X® Carbon deposited on a graphite substrate, which is impregnated with 10 weight% tungsten to provide radiopacity.
The sewing cuff is constructed of polytetrafluoroethylene (PTFE) fabric mounted on the orifice using titanium retaining rings and 5-0 suture material. This form of sewing cuff attachment to the orifice allows for rotation of the sewing cuff in situ during implantation. Orientation reference marks are provided on the sewing cuff for valve orientation.
The On-X® Prosthetic Heart Valve is available in 3 aortic and 2 mitral sewing cuff configurations. Aortic configurations are available in sizes 19, 21, 23, 25, and 27/29 mm. The standard mitral cuff is available in sizes 23, 25, 27/29 and 31/33, while the Conform-X® mitral cuff is available in size 25/33 only.
Further detail for the On-X prosthetic heart valve is described in the Summary of Safety and Effectiveness documents for the On-X heart valves: http://www.accessdata.fda.gov/cdrh_docs/pdf/P000037b.pdf (aortic), and http://www.accessdata.fda.gov/cdrh_docs/pdf/P000037S001b.pdf (mitral).
ON-X LIFE TECHNOLOGIES, INC.
ONXAN-23
In Commercial Distribution
- 00851788001617 ()
- Outer Diameter: 23 Millimeter
- Aortic bi-leaflet mechanical heart valve prosthesis