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510(k) Data Aggregation
K Number
K133781Device Name
DECLIPSESPECT LAPAROSCOPY
Manufacturer
SURGICEYE GMBH
Date Cleared
2014-04-11
(120 days)
Product Code
IZD
Regulation Number
892.1320Why did this record match?
Applicant Name (Manufacturer) :
SURGICEYE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
declipseSPECT Laparoscopy is an enhancement of the declipseSPECT system for minimal invasive surgery using a laparoscopic gamma probe. declipseSPECT Laparoscopy works in conjunction with a laparoscopic nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. declipseSPECT Laparoscopy is intended to use the said detector and generate images of the distribution of radionuclides in the human body and determine the 3D localization of these radionuclides relative to surgical instruments by means of tracking technologies and image reconstruction techniques. The declipseSPECT Viewer is also intended to be used for hybrid nuclear medicine image viewing in-situ, such as SPECT/CT and PET/CT.
declipseSPECT Laparoscopy is used intraoperatively or on pathological specimens. For any intraoperative usage the laparoscopic gamma probe needs to be covered by a protective sterile cover. The scan and operation of the system can be performed by medical staff, including technicians, nurses, physicians that are trained to use the system.
The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel. declipseSPECT Laparoscopy is compatible currently to following nuclear uptake detectors:
| Probe<br>Manufacturer | Probe Model | Probe Handle Model | Energy range of<br>gamma rays |
|-----------------------|-------------|--------------------|-------------------------------|
| Crystal Photonics: | SG04 | CXS-OP-SZL-45 | 60-245 keV |
Device Description
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K Number
K123917Device Name
DECLIPSESPECT VIEWER
Manufacturer
SURGICEYE GMBH
Date Cleared
2013-01-25
(37 days)
Product Code
IZD
Regulation Number
892.1320Why did this record match?
Applicant Name (Manufacturer) :
SURGICEYE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
declipseSPECT Viewer works in conjunction with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. declipseSPECT Viewer is intended to use the said detector and generate images of the distribution of radionuclides in the human body and determine the 3D localization of these radionuclides relative to surgical instruments by means of tracking technologies and image reconstruction techniques. The declipseSPECT Viewer is also intended to be used for hybrid nuclear medicine image viewing in-situ, such as SPECT/CT and PET/CT.
declipseSPECT Viewer may also be used intraoperatively or on pathological specimens if a protective cover is used to cover the nuclear uptake detector. dedipseSPECT Viewer may be used at the patient's bedside, or in an Emergency Room or Intensive Care Unit. The scan and operation of the system can be performed by medical staff, including technicians, nurses, physicist and physicians that are trained to use the system.
The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel.
Device Description
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K Number
K101887Device Name
CONFIDENT SURGERY SUITE 300, MODEL CSS300
Manufacturer
SURGICEYE GMBH
Date Cleared
2011-03-22
(259 days)
Product Code
IZD
Regulation Number
892.1320Why did this record match?
Applicant Name (Manufacturer) :
SURGICEYE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Confident Surgery Suite 300 (CSS300) works in conjunction with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. CSS300 is intended to extend the said detector and generate images of the distribution of radionuclides in the human body by means of tracking technologies and image reconstruction techniques. CSS300 extends currently all nuclear uptake detectors by Crystal Photonics. CSS300 may also be used intraoperatively or on pathological specimens if a protective sheath is used to cover the nuclear uptake detector. CSS300 may be used at the patient's bedside, or in an Emergency Room or Intensive Care Unit. The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel.
Device Description
CSS300 is an extension for nuclear uptake detectors designed to obtain 3D images from small organs and structures labeled using radionuclides emitting gamma rays by acquiring data while moving freely with the hand the said detectors. Examples of nuclear uptake detectors compatible with CSS300 are the nuclear uptake detectors by Crystal Photonics. CSS300 includes also analysis and display equipment, an optical camera, a cart and an ergonomic arm which allows positioning the required positioning sensor and camera in a suitable position while using the device.
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