DEVICE: Surgical 3D Video Microscope KestrelView II (04589698450206)
Device Identifier (DI) Information
Surgical 3D Video Microscope KestrelView II
KV2
In Commercial Distribution
MITAKA KOHKI CO., LTD.
KV2
In Commercial Distribution
MITAKA KOHKI CO., LTD.
The KV2 is for use as surgical microscope designed to magnify minute structuresin the fields for surgery.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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57883 | Surgical microscope fluorescent angiography system |
A non-sterile, mains electricity (AC-powered) device assembly designed for viewing intraoperative blood flow in the cerebral vascular area, in bypass grafts during coronary artery bypass graft (CABG) surgery, and during plastic and reconstructive surgery. It enables a surgical microscope to produce excitation light and resolve fluorescence from the fluorescent agent indocyanine green (ICG). Fluorescent signals depict the distribution of the infrared dye in the patient's blood vessels during the operation. The system is attached to a compatible surgical microscope and typically includes an ICG filter, a near infrared (NIR) charge-coupled device (CCD) video camera, and connecting cables.
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Active | false |
12538 | ENT surgical microscope |
A light (optical) magnification instrument designed to magnify minute structures (e.g., nerves, vessels) in the performance of ear, nose, and/or throat (ENT) surgery requiring high magnification and adjustable focusing. It typically consists of a stereo microscope (standard or modified) and a mobile floor stand or wall or ceiling mount. It is usually held by an adjustable arm attached to the support mechanism and equipped with motorized focusing, adjustable magnification systems (manual, zoom, or both), backup lamps, and inclined tubes. Dual- or multiple-observation capability and the optical integration of still, motion picture, and TV cameras are common features.
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Active | false |
41596 | Surgical microscope stand |
A mobile device onto which a surgical microscope (not included) is designed to be mounted/secured to enable dynamic positioning of the surgical microscope during surgical procedures. It is designed as a floor stand with a vertical base on wheels and typically with articulated arms that connect to the microscope; in addition, various microscope functions may be controlled from the mount such as movement (motor-assisted), light intensity, zoom, or colour balance.
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Obsolete | false |
37184 | Microscope objective |
A lens or lens group that forms the part of the optical system of a microscope closest to the object. It is used to magnify the viewed image. The objective may be supplied singularly, in pairs, or in sets of increasing magnification.
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Active | false |
41895 | Neurosurgical microscope |
A light (optical) magnification instrument, usually stereoscopic, designed to magnify minute structures within the neurological fields for surgery, typically the brain or spine or surroundings in the performance of neurological surgical procedures which require high magnification by transmitted light. It will often be equipped with motorized focusing, adjustable magnification mechanisms (manual, zoom or both), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It is usually fixed.
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Active | false |
35191 | General-purpose surgical microscope |
A general-purpose, surgical, light (optical) magnification instrument, usually stereoscopic, designed to magnify minute structures, e.g., nerves or vessels in the performance of delicate surgical procedures which require high magnification by transmitted light. An operating microscope will often be equipped with motorized focusing, adjustable magnification mechanisms (manual, zoom or both), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It can be fixed or mobile.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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EPT | Microscope, Surgical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ce95be3b-e296-4562-b9f6-741a80909d43
August 21, 2019
2
September 03, 2018
August 21, 2019
2
September 03, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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Secondary DI
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Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined