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510(k) Data Aggregation
K Number
K152489Device Name
ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray
Manufacturer
PANORAMIC CORP.
Date Cleared
2016-02-04
(156 days)
Product Code
OAS
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
PANORAMIC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ENCOMPASS Eagle 3D is intended to acquire two-dimensional digital panoramic and cephalometric radiographies, and multi-field of view 3D computed tomography images of dento-maxillo-facial region for the purpose of advanced diagnosis at the direction of qualified dental healthcare professionals
Device Description
The ENCOMPASS Eagle 3D is a complete 3-in-1 system for dental imaging capable of make Tomography, Digital Panoramic Profiles and Digital Cephalometric Profiles. The machine uses a CCD sensor technology with the traditional scintillator technologies and auto image processing that speeds up the diagnostic and improves the clinic workflow. The equipment has three movement axes (two in orthogonal directions and one rotational) making it possible to execute elaborate imaging profiles. It features a complex profile movement around the dental arch and radiographic emission compensation in the spinal region, when necessary reconstructing the dental arch into a plane image. Each individual profile prioritizes a set of characteristics improving diagnostic capabilities. For example, the standard panoramic prioritizes image layer width, constant vertical magnification and homogeneous exposure along the whole image. Likewise, the low dosage profile prioritizes the reduction of dosage (time and anodic current).
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K Number
K141130Device Name
ENCOMPASS
Manufacturer
PANORAMIC CORP.
Date Cleared
2014-07-30
(90 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
PANORAMIC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For diagnostic radiographic use in dental, oral surgery, and orthodontic practices.
Device Description
The ENCOMPASS HF100-Eagle Panoramic X-Ray Machine with CCD sensor is a complete system for dental imaging capable of Digital Panoramic Profiles and Digital Cephalometric Profiles. The machines use a sensor CCD sensor technology with the traditional scintillator technologies and auto image processing that allow a speed up the diagnostic and improve the clinic workflow. The equipment has three movement axes (two in orthogonal directions and one rotational) making it possible to execute elaborate imaging profiles. It features a complex profile movement around the dental arch and radiographic emission compensation in the spinal region, when necessary reconstructing the dental arch into a plane image. Each individual profile prioritizes a set of characteristics improving diagnostic capabilities. For example, the standard panoramic prioritizes image layer width, constant vertical magnification and homogeneous exposure along the whole image. Likewise, the low dosage profile prioritizes the reduction of dosage (time and anodic current). ONLY THE SENSOR HAS CHANGED.
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K Number
K110371Device Name
ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY
Manufacturer
PANORAMIC CORP.
Date Cleared
2011-03-17
(37 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
PANORAMIC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Panoramic or Cephalometric diagnostic radiographic use in dental, oral surgery, and orthodontic practices.
Device Description
The ENCOMPASS HF100- Eagle Panoramic X-Ray Machine is a complete system for dental imaging capable of: Film Panoramic Profiles Film Cephalometric Profiles Digital Panoramic Profiles Digital Cephalometric Profiles The digital machines use a sensor with CdTe/CMOS technology for imaging that allows for direct conversion between x-ray photons into voltage levels making it less noisy than traditional scintillator technologies. The equipment has three movement axes (two in orthogonal directions and one rotational) making it possible to execute elaborate imaging profiles. It features a complex profile movement around the dental arch and radiographic emission compensation in the spinal region, when necessary reconstructing the dental arch into a plane image. Each individual profile prioritizes a set of characteristics improving diagnostic capabilities. For example, the standard panoramic prioritizes image layer width, constant vertical magnification and homogeneous exposure along the whole image. Likewise, the low dosage profile prioritizes the reduction of dosage (time and anodic current).
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K Number
K043557Device Name
MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS
Manufacturer
PANORAMIC CORP.
Date Cleared
2005-01-13
(17 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
PANORAMIC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For diagnostic radiographic use in dental, oral surgery, and orthodontic practices.
Device Description
The PC-1000 panoramic X-ray machine provides a panoramic picture, showing 70-80% more anatomy than a standard series of full-mouth X-rays. Inscribed lines and an angled mirror aid in accurately establishing the Frankfort plane and the midsagittal plane. In addition, the numbered temple supports allow accurate measurement of skull density for proper kVp settings, eliminating the guess work typical in panoramic radiography.
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