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510(k) Data Aggregation
K Number
K111361Device Name
PLANMED NUANCE EXCEL
Manufacturer
PLANMECA USA, INC.
Date Cleared
2011-09-23
(130 days)
Product Code
MUE
Regulation Number
892.1715Why did this record match?
Applicant Name (Manufacturer) :
PLANMECA USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Planmed Nuance Excel is a FFDM (Full Field Digital Mammography) X-ray unit, which is intended to be used for screening and diagnosis of breast cancer in the same clinical applications as traditional film/screen mammography X-ray units.
The system generates digital mammograms which enable to detect breast cancer at an early stage. The use of Planmed FFDM X-ray unit is allowed only under supervision of a health care professional.
Device Description
The Planmed Nuance Excel is a Full Field Digital Mammography (FFDM) system for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Planmed Nuance utilizes an amorphous selenium based digital image receptor to capture digital images. The receptor directly converts the incoming X-ray photons to digital image data.
The workflow with Planmed Nuance Excel is controlled from the acquisition workstation and Planmed Nuance Manager 3 image acquisition and communications software. The patient information is entered manually or received from the hospital, radiology, or mammography information systems (HIS, RIS, or MIS, respectively), as a format of modality work list. Subsequently, the images are acquired, processed, and displayed for preview. After initial evaluation by the user, the images are either printed or transferred for soft-copy review.
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K Number
K081699Device Name
PLANMECA SOVEREIGN
Manufacturer
PLANMECA USA, INC.
Date Cleared
2008-08-29
(73 days)
Product Code
EIA
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
PLANMECA USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Planmeca Sovereign is a dental operative unit, which is an ACpowered device that is intended to supply power to and serve as a base for other dental devices and accessories. The device includes a dental patient chair, which is intended to properly position a patient to perform different dental procedures. The device is to be operated and used by dentists and other legally qualified professionals.
Device Description
The Planmeca Sovereign is a dental operative unit including a dental patient chair. The design is very flexible with many motorized functions, and both left-handed and righthanded use is easily obtainable. The dentist and assistant are allowed to change their working postures according to the operation to be performed. The versatile swivelling enables fluent two-handed and four-handed treatment sequences. The unit is equipped with a digital control system with graphical user interface (GUI) to offer ease-of-use. The instrument console includes six instrument locations, with easy instrument interchange.
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