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Found 5 results
510(k) Data Aggregation
K Number
K183142Device Name
PathVisionXL
Manufacturer
Faxitron Bioptics LLC
Date Cleared
2019-03-14
(121 days)
Product Code
MWP
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Faxitron Bioptics LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PathVisionXL is a Cabinet x-ray system that is used to provide film and/or digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification directly in the same room or nearby enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.
Device Description
The PathVisionXL is specially designed for high detail radiographic imaging of surgically excised medical specimens. It is a fully shielded Cabinet X- ray System that has been designed to comply with 21 CFR 1020.40. The larger (XL) cabinet allows up to 10.0 times geometric magnification of excised specimens with minimal geometric distortion through the use of a focal spot size that is less than 15 microns. With optimized cabinet geometry and the superior contrast available from the low kV capability, the PathVisionXL provides enhanced image performance. It is designed to acquire a large high resolution digital images up to 43 x 43 cm in size, through the use an integrated digital X-Ray detector and Faxitron Vision software. The Faxitron Software supports the DICOM Store, Print and Modality Worklist services.
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K Number
K173309Device Name
Faxitron VisionCT
Manufacturer
Faxitron Bioptics Llc
Date Cleared
2018-05-09
(203 days)
Product Code
MWP, RAD
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Faxitron Bioptics Llc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Faxitron VisionCT is a Cabinet x-ray system that is used to provide two and three dimensional digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification directly in the same room or nearby enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.
Device Description
The Faxitron VisionCT is specially designed for high detail radiographic imaging of surgically excised medical specimens. It is a fully shielded Cabinet X- ray System that has been designed to comply with 21 CFR 1020.40. It allows up to 4.0 times geometric magnification of excised specimens with minimal geometric distortion through the use of a focal spot size that is less than 15 microns. With optimized cabinet geometry and the superior contrast available from the low kV capability. the VisionCT provides enhanced image performance. It is configured to acquire high resolution digital images up to 15 x 15 cm in size, through the use an integrated detector and Faxitron Vision Specimen Radiography software. The Faxitron Software supports the DICOM Store, Print and Modality Worklist services.
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K Number
K170786Device Name
Faxitron Bioptics Speciemen Radiography System
Manufacturer
Faxitron Bioptics LLC
Date Cleared
2017-07-18
(124 days)
Product Code
MWP
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Faxitron Bioptics LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VersaVision is a Cabinet x-ray system that is used to provide film and/or digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification directly in the same room or nearby enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.
Device Description
The Faxitron VersaVision Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens. The exceptionally high magnification capability (up to 8X) from the <15 micron focal spot with optimized cabinet geometry and the superior contrast available from the low kV capability provides enhanced film and/or digital imaging performance. This device supports radiographic film sizes up to 15 x 24 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images up to 15 x 24 cm in size through the use an integrated detector and Faxitron Vision Specimen Radiography software.
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K Number
K153583Device Name
BioVision Plus
Manufacturer
FAXITRON BIOPTICS LLC
Date Cleared
2016-04-01
(108 days)
Product Code
MWP
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
FAXITRON BIOPTICS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BioVision (Plus/ +)Digital Specimen Radiography (DSR) System is a cabinet digital X-ray imaging system intended to generate and control X-rays for examination of harvested specimens from various anatomical regions, and to provide rapid verification that the correct tissue has been excised.
Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls. This device is intended to be operated wherever the medical professionals deem appropriate, including a surgical suite or a room adjacent to a surgical suite.
Device Description
The BioVision(Plus) Digital Specimen Radiography (DSR) System is a standalone cabinet digital X-ray imaging system designed to provide rapid verification that the correct tissue has been excised.
Performing the verification directly in the same procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.
The BioVision(Plus) Digital Specimen Radiography (DSR) System employs the use of Faxitron Bioptics Vision image acquisition software. The Vision software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal.
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K Number
K122428Device Name
FAXITRON SPECIEN RADIOGRAPHY SYSTEM
Manufacturer
FAXITRON BIOPTICS LLC
Date Cleared
2012-09-25
(47 days)
Product Code
MWP
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
FAXITRON BIOPTICS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PathVision is a Cabinet x-ray system that is used to provide film and/or digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification directly in the same room or nearby enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.
Device Description
The Faxitron PathVision Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens. The exceptionally high magnification capability (up to 6X) from the 0.02 mm focal spot with optimized cabinet geometry and the superior contrast available from the low kV capability provides enhanced film and/or digital imaging performance. This device supports radiographic film sizes up to 35 x 35 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images up to 23 x 29 cm in size through the use an integrated camera and Faxitron Specimen Radiography software.
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