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510(k) Data Aggregation
K Number
K192408Device Name
Custodiol HTK Solution
Manufacturer
Date Cleared
2020-04-24
(233 days)
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
Franz Kohler Chemie GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CUSTODIOL® HTK solution is indicated for perfusion and flushing of donor kidneys, liver, pancreas and heart prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation to the patient. CUSTODIOL® HTK solution is not indicated for continuous machine perfusion of donor organs.
Device Description
The CUSTODIOL® HTK solution is intended for perfusion and flushing donor kidney, liver, heart, and pancreas prior to removal from the donor and for preserving these organs during hypothermic storage and transport to the recipient. CUSTODIOL® HTK solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive buffering of the extracellular space by means of histidine/histidine HCI, so as to prolong the period for which the organs will tolerate interruption of blood and oxygen supply. Only a small portion of the osmolality of the CUSTODIOL® HTK solution is due to the sodium and potassium. The composition of HTK is similar to that of extracellular fluid. All of the components of the CUSTODIOL® HTK solution occur naturally in the body. The CUSTODIOL® HTK solution is relatively low in potassium concentration so that residual solution in the transplanted organ poses no danger to the recipient. This is particularly important in orqans that take up relatively large amounts of the perfusate, which may find its way into the recipient's circulation. The CUSTODIOL® HTK solution has a low viscosity, even at low temperatures. This characteristic assures rapid flow rates during initial perfusion, allowing the organ to be quickly cooled.
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K Number
K130269Device Name
ECAT SCINTRON PET
Manufacturer
Date Cleared
2013-04-19
(74 days)
Product Code
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
MIE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 'ECAT Scintron PET' integrated workstation is designed to acquire data, process and display images, by appropriated trained health care professionals, from ECAT EXACT and ECAT ACCEL PET scanners of CTI PET Systems via measuring the distribution of injected positron emitting radiopharmaceutical in humans for purpose of determining various metabolic and physiologic functions within the human body.
Device Description
The 'ECAT SCINTRON PET' is designed to replace the integrated workstation (advanced computational system) of the legally market devices ECAT EXACT PET System and ECAT ACCEL PET scanner. The 'ECAT SCINTRON PET' integrated workstation is proposed to perform simultaneous 2D or 3D acquisitions, image reconstruction, processing and analysis of data received from ECAT Positron Emission Tomographs of CTI PET Systems. In addition it controls the motion of the patient handling system, the transmission sources and septa for 2D scans with the scanner. The 'ECAT SCINTRON PET' is used to acquire data from whole body positron emission tomography system and providing 3D volume measurements of metabolic and physiologic processes. The software is designed to run only on 'ECAT SCINTRON PET' integrated workstations. The software is only available as package and in combination with the computer hardware. Some software modules not needed for the basic usage are optional. The development processes of the software and hardware are based on the legally market device, name SCINTRON, K101013. The 'ECAT SCINTRON PET' uses industry standard and well tried hardware components and software techniques which ensures long term support.
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K Number
K101768Device Name
MIE SCINTRON GAMMA CAMERA SYSTEMS
Manufacturer
Date Cleared
2010-10-05
(104 days)
Product Code
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
MIE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ECAM SCINTRON Gamma Camera System for diagnostic nuclear medicine is used to perform static, dynamic and gated studies (non positron emitting tomography), as well as SPECT or planar procedure on standing, seated or recumbent patients.
Device Description
The ECAM SCINTRON Gamma Camera System is a remanufactured Siemens Gamma Camera with MiE Workstation. It is designed for diagnostic nuclear medicine used to perform static, dynamic and gated studies (non positron emitting tomography), as well as SPECT or planar procedure on standing, seated or recumbent patients.
The ECAM SCINTRON Gamma Camera System is substantially equivalent to the legally market device e.cam, K963983, from Siemens and our device SCINTRON, K101013.
The changes incorporated into the remanufactured ECAM Gamma Camera include economical and ecological issues. This closes the gap between more durable electronics and mechanics lifetimes and shortened development cycles.
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K Number
K101013Device Name
MODIFICATION TO SCINTRON IV
Manufacturer
Date Cleared
2010-06-07
(56 days)
Product Code
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
MIE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SCINTRON workstation for diagnostic nuclear medicine is designed for acquiring, processing and reviewing data from all type of MiE and Siemens digital and analog gamma cameras. The SCINTRON is used to perform statis. dynamic and gated studies, as well as SPECT (non positron sitting tomography), whole body or planar procedure, on standing, seated or recumbent patients.
Device Description
The SCINTRON is the modification and development of the SCINTRON IV. It is designed with Graphical User Interfaces for data acquisition, reviewing and processing of analog and digital Siemens gamma cameras. It controls static, dynamic, SPECT and whole body acquisitions. The SCINTRON uses industry standard and well tried PowerPC CPU on VMEbus which ensures long term support. Additionally to the clinical and networking programs, a variety of basic functions are available.
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K Number
K043461Device Name
CUSTODIOL
Manufacturer
Date Cleared
2005-02-28
(75 days)
Product Code
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
FRANZ KOHLER CHEMIE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Custodiol HTK Solution is indicated for perfusion and flushing donor kidneys, liver, pancreas, and heart prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation (not for continuous perfusion) to the recipient.
Device Description
The HTK solution is intended for perfusion and flushing donor kidney, liver, heart, and pancreas prior to removal from the donor and for preserving these organs during hypothermic storage and transport to the recipient. HTK solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive buffering of the extracellular space by means of histidine/histidine HCI, so as to prolong the period for which the organs will tolerate interruption of blood and oxygen supply. Only a small portion of the osmolality of the HTK solution is due to the sodium and potassium. The composition of HTK is similar to that of extracellular fluid. All of the components of the HTK solution occur naturally in the body. The HTK solution is relatively low in potassium concentration so that residual solution in the transplanted organ poses no danger to the recipient. This is particularly important in organs that take up relatively large amounts of the perfusate, which may find its way into the recipient's circulation. The HTK solution has a low viscosity, even at low temperatures. This allows the organ to be quickly cooled.
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K Number
K032794Device Name
CUSTODIOL
Manufacturer
Date Cleared
2004-04-05
(210 days)
Product Code
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
FRANZ KOHLER CHEMIE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Custodiol HTK Solution is indicated for perfusion and flushing donor kidneys, livers, and hearts prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation (not for continuous perfusion) to the recipient.
Device Description
The HTK solution is intended for perfusion and flushing donor hearts prior to removal from the donor and for preserving the heart during hypothermic storage and transport to the recipient. HTK solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive buffering of the extracellular space by means of histidine/histidine HCI, so as to prolong the period for which the organs will tolerate interruption of blood and oxygen supply. Only a small portion of the osmolality of the HTK solution is due to the sodium and potassium. The composition of HTK is similar to that of extracellular fluid. All of the components of the HTK solution occur naturally in the body. The HTK solution is relatively low in potassium concentration so that residual solution in the transplanted organ poses no danger to the recipient. This is particularly important in organs that take up relatively large amounts of the perfusate, which may find its way into the recipient's circulation. The HTK solution has a low viscosity, even at low temperatures. This characteristic assures rapid flow rates during initial perfusion, allowing the organ to be quickly cooled.
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K Number
K020924Device Name
CUSTODIOL HTK SOLUTION
Manufacturer
Date Cleared
2003-01-06
(291 days)
Product Code
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
FRANZ KOHLER CHEMIE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Custodiol HTK Solution is indicated for perfusion and flushing donor kidneys and liver prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation (not for continuous perfusion) to the recipient.
Device Description
The HTK solution is intended for perfusion and flushing donor kidneys and liver prior to removal from the donor and for preserving the kidney during hypothermic storage and transport to the recipient. HTK solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive buffering of the extracellular space by means of histidine/histidine HCI, so as to prolong the period for which the organs will tolerate interruption of blood and oxygen supply. Only a small portion of the osmolality of the HTK solution is due to the sodium and potassium. The composition of HTK is similar to that of extracellular fluid. All of the components of the HTK solution occur naturally in the body. The HTK solution is relatively low in potassium concentration so that residual solution in the transplanted organ poses no danger to the recipient. This is particularly important in organs that take up relatively large amounts of the perfusate, which may find its way into the recipient's circulation. The HTK solution has a low viscosity, even at low temperatures. This characteristic assures rapid flow rates during initial perfusion, allowing the organ to be quickly cooled.
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K Number
K992209Device Name
CUSTODIOL
Manufacturer
Date Cleared
1999-12-10
(163 days)
Product Code
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
FRANZ KOHLER CHEMIE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Custodiol HTK Solution is indicated for perfusion and flushing donor kidneys prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation (not for continuous perfusion) to the recipient.
Device Description
The HTK solution is intended for perfusion and flushing donor kidneys prior to removal from the donor and for preserving the kidney during hypothermic storage and transport to the recipient. HTK solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive buffering of the extracellular space by means of histidine/histidine HCl, so as to prolong the period for which the organs will tolerate interruption of blood and oxygen supply. Only a small portion of the osmolality of the HTK solution is due to the sodium and potassium. The composition of HTK is similar to that of extracellular fluid. All of the components of the HTK solution occur naturally in the body.
The HTK solution is relatively low in potassium concentration so that residual solution in the transplanted organ poses no danger to the recipient. This is particularly important in organs that take up relatively large amounts of the perfusate, which may find its way into the recipient's circulation.
The HTK solution has a low viscosity, even at low temperatures. This characteristic assures rapid flow rates during initial perfusion, allowing the organ to be quickly cooled.
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