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510(k) Data Aggregation
K Number
K043612Device Name
ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D
Manufacturer
INSTRUMENTARIUM CORP. IMAGING DIVISION
Date Cleared
2005-02-09
(41 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
INSTRUMENTARIUM CORP. IMAGING DIVISION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orthopantomograph® OP200 (film unit) and OP200 D (digital unit) devices are intended to be used for producing X-ray radiographs of dentition, TM-joints and other oral structures. The units are capable of taking panoramic, TM-joint and maxillary sinus radiographs from patients. When the units are equipped with cephalometric option Orthoceph® OC200 (film unit) or OC200 D (digital unit) units can be used for cephalometric radiography and examinations related thereto. OP200 or OC200 units can also be equipped with Ortho Trans (OT) option, which is capable of taking both cross and longitudinal slices of region of interest. Ortho Trans uses linear tomography imaging principle.
Device Description
Panoramic X-ray devices Orthopantomograph® OP200, OP200 D and cephalometric options Orthoceph® OC200, OC200 D are the next generation in the Orthopantomograph® and Orthoceph® family. In the case of OP200 and OC200 devices, the image is captured to the film whilst OP200 D and OC200 D offer digital imaging. The units include patented V-shaped X-ray beam that adapts to the bone density and structure of the human anatomy. In the OP200 D and OC200 D the imaging geometry remains the same as in film-based imaging (OP200, OC200), thereby enabling comparison to earlier film-based studies. The patient positioning is easy and accurate thanks to motorized movements and three light lines for correct positioning of the patient's head. The patient's midsagittal view can be seen in a panoramic mirror and the electrically locked rigid forehead support is used to stabilize the head. Patient positioning can be performed on the left or right side. When OP200 or OC200 units are equipped with CR option they have bigger 24x30cm cassette holder in panoramic side. Normal cassette holder size is 15x30cm. With this bigger 24x30cm cassette holder CR imaging plates can be used. Optional Ortho ID film marking system can be used to store exposure parameters, patient and clinic information to films. Ortho ID is connected to OP200 or OC200 film units. Equipments are designed to be field upgradeable. This means that for example basic OP200 film unit can be field upgraded to OC200 (cephalometric imaging) or OP200 D digital or OC200 D digital. All different options like OT, CR, etc. can be field upgraded afterwards.
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K Number
K023864Device Name
PERFORMA STEREO
Manufacturer
INSTRUMENTARIUM CORP. IMAGING DIVISION
Date Cleared
2003-01-09
(50 days)
Product Code
IZH
Regulation Number
892.1710Why did this record match?
Applicant Name (Manufacturer) :
INSTRUMENTARIUM CORP. IMAGING DIVISION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Performa Stereo is intended to be used for breast biopsy or lesion marking with the base mammographic system Performa with stereo adapter.
Device Description
Performa Stereo is a breast biopsy and lesion marking system in connection with the Performa mammographic system (#K981641). The Performa stereo is especially developed for fine needle aspiration (FNA), core biopsy, vacuum assisted biopsy and lesion marking. The Performa Stereo system consists of a biopsy unit with a needle guide and a breast support table, an adapter unit for making ±15° angles, and a film marker unit. A mechanical docking interface is used for connecting the Performa Stereo's stereo adapter and the biopsy unit together. There are no electrical connections between the biopsy unit and Performa.
The adapter unit is identical to adapter used in the case of Alpha Stereo 4 and Delta 16. The needle guide is a Cytoguide biopsy unit which is the same than used in the case of Delta 32.
In an examination two X-ray images are taken at angles of +15° and -15° degree of the region of interest in the breast. The image capturing will be made by 18x24 cm film cassette and the needle targeting driving will be made with the motorized Cytoguide needle guide unit which are the main functions of the biopsy unit. After making two individual stereotactic X-ray exposures to one film, the corresponding two images are shown side by side on the film reader unit. The user then marks the target point with a cursor on each image. Based on the marking the xyzcoordinates of target are calculated by the film marker unit. The needle holder is then automatically positioned, taking into account the coordinate information and the needle length selected. The tip of the needle, which is then inserted into the holder with correct bushings can now be used to penetrate the lesion area.
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K Number
K022275Device Name
DELTA 32; DELTA 32 TACT
Manufacturer
INSTRUMENTARIUM CORP. IMAGING DIVISION
Date Cleared
2002-09-12
(59 days)
Product Code
IZH
Regulation Number
892.1710Why did this record match?
Applicant Name (Manufacturer) :
INSTRUMENTARIUM CORP. IMAGING DIVISION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Delta 32 and Delta 32 TACT® are intended to be used for diagnostic digital spot and 3D imaging, and optionally for digital stereotactic breast biopsy. Delta 32 and Delta 32 TACT® are intended to be used with the base mammographic system Diamond. However, a PC workstation of Delta 32 and Delta 32 TACT® can also be used as stand-alone for viewing images taken by Delta 32 and Delta 32 TACT®. The TACT® add-on provides means for digital 3D spot imaging using 2D projection images acquired with the system.
Device Description
Delta 32 and Delta 32 TACT® is a mammographic diagnostic digital mammography spot and 3D imaging system, which can also be used for digital stereotactic breast biopsy. The base system is the Diamond mammographic system (#K955411), on which the Delta 32 and Delta 32 TACT® is installed. The images are acquired by a CCD camera identical to our Delta 32 (#K002472). The needle guiding system is the same than previously, Cytoguide biopsy unit (#K885020). A PC workstation receives images and computes the necessary needle coordinates for Cytoguide unit. The PC also performs the optional TACT® 3D reconstruction identically to the Delta 32 TACT® system described in (#K002472). The PC workstation can also be used as stand-alone for viewing digital mammography spot and 3D images taken by Delta 32 and Delta 32 TACT®.
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