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510(k) Data Aggregation
K Number
K152661Device Name
HICAT Air
Manufacturer
Date Cleared
2015-11-16
(60 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
HICAT GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HICAT Air is a software application for:
- · Aiding diagnosis in the ear-nose-throat region
- Aiding treatment planning in the ear-nose-throat region
- · Aiding comparisons of different treatment options
- · Aiding treatment planning for oral appliances
Device Description
HICAT Air is a pure software device.
HICAT Air is a software application for the visualization and segmentation of imaging information of the ear-nose-throat (ENT) region.
The imaging data originates from medical scanners such as CT or Cone Beam – CT (CBCT) scanners.
This information can be complemented by the imaging information from optical impression systems. The additional information about the exact geometry of the tooth surfaces can be visualized together with the radiological data.
HICAT Air is also used as a software system to aid qualified medical professionals with the diagnosis, and followed by the evaluation, comparison and planning of ENT treatment options.
The medical professionals' input information and planning data may be exported from HICAT Air to be used as input data for CAD or Rapid Prototyping Systems for the manufacturing of therapeutic devices such as oral devices.
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