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Found 7 results
510(k) Data Aggregation
K Number
K021236Device Name
SURGERY AND ACCESSORIES
Manufacturer
CAMTRONICS, LTD.
Date Cleared
2002-07-17
(90 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CAMTRONICS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Acquisition unit for digitizing and storing images generated during surgical proceedings that are typically related to, but not limited to, endoscopic surgery procedures.
Device Description
The Surgery Image Recorder (SIR) is an acquisition unit for digitizing and storing images generated during surgical proceedings that are typically related to, but not limited to, endoscopic surgery procedures. The SIR is designed to provide surgeons the ability to capture still images and streaming video from standard video outputs typically associated with imaging devices used during endoscopic surgery. To allow for the entry of patient demographic information and to provide a user interface the SIR will have and VO for a USB type keyboard and mouse, and will also provide I/O's for a USB compatible color printer, video outputs, serial outputs and network connectivity. Additionally, the SIR will be able to store data to its internal hard disk drive and to removable storage media (e.g., DVD, CD-R).
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K Number
K013032Device Name
PHYSIOLOG, SERIES 95000
Manufacturer
CAMTRONICS, LTD.
Date Cleared
2002-06-04
(267 days)
Product Code
DQK, DOK
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
CAMTRONICS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VERICIS Physiolog monitors, measures, and/or records physiologic data and patient images from a patient undergoing a cardiac catheterization procedure. VERICIS Physiolog is intended for use in hospital cardiac catheterization laboratories.
Device Description
VERICIS Physiolog monitors, measures, and/or records physiologic data and patient images from a patient undergoing a cardiac catheterization procedure. VERICIS Physiolog is intended for use in hospital cardiac catheterization laboratories.
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K Number
K992666Device Name
VIDEO PLUS SYSTEM, SERIES 95000
Manufacturer
CAMTRONICS, LTD.
Date Cleared
1999-10-13
(65 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CAMTRONICS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Video Plus is a digital imaging acquisition and review system for the cardiac video Fras is a cigation findedigital fluoroscopy, digital fluoroscopy, digital cine, real time cannoterization no. To icatalor meterssing, image processing, quantitative coronary processing digital subtraction angiography, digital video input, linked biplane acquisition, auto injection, and histogram equalization.
Device Description
This is a software upgrade for the existing Video Plus System cleared under K954159. This release encompasses some general enhancements and more integrated support for certain vendors.
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K Number
K992259Device Name
ECHOCARDIOGRAPHY SYSTEM SERIES 95000
Manufacturer
CAMTRONICS, LTD.
Date Cleared
1999-09-08
(64 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CAMTRONICS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A digital image capture, storage, and review system for echocardiography.
Device Description
The Echocardiography System provides a digital image transport and archive solution for hospitals wishing to replace their current VCR-based system. Currently, a typical cardiac echo department operates by manually shuttling VCR tapes between echo machines and VCR players. The Echocardiography System provides a high-speed digital link between these nodes. It also supports digital archival of echo exams in order to eliminate the cost and inconvenience of permanent storage via VCR tapes.
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K Number
K990066Device Name
CCD CAMERA, MODEL 9000
Manufacturer
CAMTRONICS, LTD.
Date Cleared
1999-03-17
(68 days)
Product Code
LMA
Regulation Number
892.2030Why did this record match?
Applicant Name (Manufacturer) :
CAMTRONICS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is a Charge Coupled Device (CCD) video camera for use in digital radiography, including DSA, high resolution cardiology, and low dose fluoroscopy. It is designed for use with X-ray image intensifiers in diagnostic imaging chains.
Device Description
This device is a Charge Coupled Device (CCD) video camera for use in digital radiography, including DSA, high resolution cardiology, and low dose fluoroscopy. It is designed for use with X-ray image intensifiers in diagnostic imaging chains.
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K Number
K955519Device Name
ANALYTICAL REVIEW STATION
Manufacturer
CAMTRONICS, LTD.
Date Cleared
1996-05-09
(157 days)
Product Code
IZI
Regulation Number
892.1600Why did this record match?
Applicant Name (Manufacturer) :
CAMTRONICS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is intended primarily for on-line or remote viewing of cardiac catheterization angiography studies communicated by network, or transported by CD-R interchage media. The CD-R media may also be used as a full resolution digital image archive of complete cath lab studies, to replace cine film. The ARS2 can optionally be used with other digital imaging modalities, such as R/F, nuclear and ultrasound. The ARS2 provides the capability to write and read CD-R optical discs which are produced in accordance with the ACC/NEMA DICOM standard.
Device Description
Digital image recording and display system for use in cardiac catheterization, radiography/fluoroscopy, ultrasound, or other digital imaging modalities.
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K Number
K954159Device Name
DIGITAL IMAGING SYSTEM
Manufacturer
CAMTRONICS, LTD.
Date Cleared
1996-03-19
(196 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CAMTRONICS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Image Acquisition .
- . Display Control/Image Processing
- Input /Output Control .
- . Patient Data Management
Device Description
Digital image recording and display system fo use in a cardiac catheterization laboratory or radiography/fluoroscopy suite.
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