Prosolv CardioVascular

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Profile: Prosolv CardioVascular deals in multi-modality image review, analysis and user-defined customized reports in a non-proprietary, open architecture environment. We support all DICOM and HL7 integrations for a complete paperless workflow.

45 Products/Services (Click for related suppliers)

• Automatic Radiographic Film Processor (FDA Code: IXW / 892.1900)

An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.

• Diagnostic Ultrasonic Transducer (FDA Code: ITX / 892.1570)

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

• Electric Biopsy Forceps (FDA Code: KGE / 876.4300)

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

• Endoscope Accessories (FDA Code: KOG)

• Endoscopic Cytology Brush (FDA Code: FDX / 876.1500)

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Endoscopic Electrosurgical Unit and Accessories (FDA Code: KNS / 876.4300)

• Endoscopic Television Camera without Audio (FDA Code: FWF / 878.4160)

A surgical camera and accessories is a device intended to be used to record operative procedures.

• Endoscopic Video Imaging System/Component (FDA Code: FET / 876.1500)

• Enteroscope and Accessories (FDA Code: FDA / 876.1500)

• Fiberoptic Endoscope (FDA Code: GDB / 876.1500)

• Flexible Snare (FDA Code: FDI / 876.4300)

• Flexible/Rigid Bronchoscope (FDA Code: EOQ / 874.4680)

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

• Flexible/Rigid Choledochoscope and Accessories (FDA Code: FBN / 876.1500)

• Flexible/Rigid Colonoscope and Accessories (FDA Code: FDF / 876.1500)

• Flexible/Rigid Duodenoscope and Accessories (FDA Code: FDT / 876.1500)

• Flexible/Rigid Gastroscope and Accessories (FDA Code: FDS / 876.1500)

• Flexible/Rigid Nasopharyngoscope (FDA Code: EOB / 874.4760)

A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

• Flexible/Rigid Sigmoidoscope and Accessories (FDA Code: FAM / 876.1500)

• General & Plastic Surgery Colonoscope (FDA Code: FTJ / 876.1500)

• General & Plastic Surgery Gastroscope (FDA Code: GCK / 876.1500)

• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500)

• Hysteroscope and Accessories (FDA Code: HIH / 884.1690)

A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

• Mammographic X-Ray System Full Field Digital (FDA Code: MUE / 892.1715)

A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.

• Mobile Fluoroscopic X-Ray System (FDA Code: IZL / 892.1720)

A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Mobile X-Ray System (FDA Code: IZL / 892.1720)

• Non-Electric Biopsy Forceps (FDA Code: FCL / 876.1075)

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Picture Archiving & Communications Systems

• Picture Archiving System Installation Service

• Programmable Diagnostic Computer (FDA Code: DQK / 870.1425)

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

• Radiographic Film (FDA Code: IWZ / 892.1840)

Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures.

• Radiographic Film Cassette (FDA Code: IXA / 892.1850)

A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.

• Radiographic Intensifying Screen (FDA Code: EAM / 892.1960)

A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.

• Radiological Digital Image Communication System (FDA Code: LMD / 892.2020)

A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol.

• Radiological Digital Image Storage Device (FDA Code: LMB / 892.2010)

A medical image storage device is a device that provides electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory.

• Radiological Image Processing System (FDA Code: LLZ / 892.2050)

A picture archiving and communications system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification.

• Radiological Multi Format Camera (FDA Code: LMC / 892.2040)

A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.

• Radiological Quality-Assurance Instrument (FDA Code: LHO / 892.1940)

A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.

• Routine Fiberoptic Light Source (FDA Code: FCW / 876.1500)

• Software Programs

• Solid State X-Ray Imager (FDA Code: MQB / 892.1680)

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Stationary X-Ray System (FDA Code: KPR / 892.1680)

• Surgical Camera and Accessories (FDA Code: KQM / 878.4160)

• Ultrasonic Puls-Echo Scanner (FDA Code: IYO / 892.1560)

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Unipolar Laparoscopic Coagulator (FDA Code: HFG / 884.4160)

A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.

• Xenon Arc Endoscope Light Source (FDA Code: GCT / 876.1500)