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510(k) Data Aggregation
K Number
K002608Device Name
INVAC
Manufacturer
Date Cleared
2000-11-16
(87 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
DUNCAN HYND ASSOCIATES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K981911Device Name
PROFA
Manufacturer
Date Cleared
1998-11-12
(164 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
DUNCAN HYND ASSOCIATES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For radiation therapy, patient/body contouring, virtual simulation and verification of the patient's treatment plan. Provides any simulator with a fast, non-contact method for obtaining accurate patient contours. The results can be downloaded to the treatment planning computer. Profa is fully automatic and offers software solution for scanning and simulation of the breast, pelvis, head and neck, treatment masks and sagittal cases. The hand-held Profa plus system is portable and can be used in the radiotherapy room.
Device Description
PROFA an Optical Patient Contouring Device
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