Superdimension Inc.

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Web: http://www.superdimension.com
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Address: 161 Cheshire Lane North, Suite 100, Minneapolis, Minnesota 55441, USA
Phone: +1-(763)-210-4000, 800-387-9016 | Fax: +1-(866)-706-9639 | Map/Directions >>

Profile: Superdimension Inc. develops and markets minimally-invasive pulmonology devices. Our superDimension inReach™ System enables physicians to access peripheral lung lesions and mediastinal lymph nodes with a minimally invasive technique suitable even for patients who cannot undergo more invasive procedures. The inReach™ System components include a disposable guide catheter, a disposable steerable navigation catheter that contains a location sensor, planning & navigation software, and hardware that includes a localization system, computer & monitor. This system is used in bronchoscopic procedures to reach peripheral lung lesions and mediastinal lymph nodes to diagnose, potentially treat and stage treatment for lung disease and lung cancer.

FDA Registration Number: 3004962788

7 Products/Services (Click for related suppliers)

• Computed Tomography X-Ray System (FDA Code: JAK / 892.1750)

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Disposable Aspiration and Injection Needle (FDA Code: GAA / 878.4800)

A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Disposable Guide Catheters

• Endoscope Accessories (FDA Code: KOG)

• 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.

• 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.

• Steerable Navigation Catheters