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510(k) Data Aggregation
K Number
K112981Device Name
SUN 125C IONIZATION CHAMBER
Manufacturer
SUN NUCLEAR CORP.
Date Cleared
2012-01-25
(111 days)
Product Code
LHN
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
SUN NUCLEAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ionization Chamber model 1041 is intended for the purpose of calibrating and measuring the ionizing radiation output from medical radiation therapy machines. This includes beam scanning as well as absolute dose calibration.
Device Description
The Sun Nuclear model 1041 "SUN125c" is a waterproof, fully-guarded, cylindrical "thimble" type ionization chamber constructed primarily of ABS plastic. The chamber is mounted to a lownoise, high impedance triaxial cable which is terminated with either a bayonet (BNC) or threaded triaxial (TNC) connector. The ionization volume of the chamber is 0.125 cc, which is appropriate for beam scanning and absolute dose measurements. This active volume is vented to the atmosphere through the cable sheath, allowing for conventional air density corrections.
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K Number
K101992Device Name
3D SCANNER, MODEL 1230
Manufacturer
SUN NUCLEAR CORP.
Date Cleared
2010-10-01
(78 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
SUN NUCLEAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3D Scanner system, model 1230, is intended for radiotherapy dosimetry measurements and export of those measurements for commissioning a treatment planning system (TPS) computer. It is also intended for periodic beam quality assurance (QA) tests as defined by the medical physicist responsible for the QA program.
Device Description
The 3D Scanner Model 1230 is an electromechanical and software system that includes:
1. a cylindrical tank to contain the water:
2. a 3 axis computer controlled scanning mechanism that is mounted on the tank,
3. a field detector mount that moves with the scan mechanism,
4. a reference detector mount that remains stationary during a scan,
5. electrometers with chamber polarization voltage supplies for said mounted detectors,
6. motor controllers for the 3 axis scanning mechanism,
7. a water level sensor that locates the water surface,
8. computer code that controls the detector location and records the detector's dosimetry data,
9. a user interface to the computer that enables
a. automatic data collection at pre-programmed field detector locations,
b. data processing and analysis that enable data transfer to the TPS system,
10. an optional EDGE detector (diode) for waterproof Field scanning and Reference
11. an optional leveling platform
12. an optional lift table accessory to support the tank
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K Number
K092019Device Name
MODEL 1014 PC ELECTROMETER
Manufacturer
SUN NUCLEAR CORP.
Date Cleared
2009-09-15
(71 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
SUN NUCLEAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PC Electrometer Model 1014 is a dosimetry electrometer intended for measuring the output charge of an ion chamber in a radiotherapy beam and using these measurements in dosimetry protocols, such as Report 67 as recommended by the AAPM Task Group #51. . In addition the PC Electrometer Model 1014 is intended for measurements with ion chamber or diode detectors as recommended during periodic QA testing protocols such as Report 46, Comprehensive QA for Radiation Oncology, as recommended by the AAPM Task Group #40. as well as AAPM Report 13 (TG-22, 24 and soon to be published TG-142, an update to TG-40.
Device Description
The PC Electrometer Model 1014 has two triaxial BNC inputs for connection to ion chambers for dosimetric measurements. The ion chamber voltage bias can be adjusted to various levels at either polarity. For air density correction, there are internal temperature and pressure sensors that measure ambient conditions and an input for an external remote temperature sensor. A USB port provides power and data communication with a Personal Computer (PC) which runs the application software to display and record data; an auxiliary power jack is also provided in case USB power is not available. The conductive enclosure (4cm x 10.5cm x 14cm) provides EMI shielding and LED status indicators. The PC Electrometer Model 1014 is a Radiation Oncology Medical Physics tool used to measure ion current from either ion chambers or diode dosimeter. These applications include periodic or annual calibration of the radiation output of the delivery machine when a calibrated ion chamber is connected such as AAPM Report 67 (TG-51) as well as periodic QA applications that do not require calibrated radiation detectors, such as described in AAPM Report 13 (TG-22, 24), AAPM Report 46 (TG-40) TG-40 and soon to be published TG-142, an update to TG-40.
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K Number
K063021Device Name
PROFILER 2
Manufacturer
SUN NUCLEAR CORP.
Date Cleared
2006-11-22
(51 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
SUN NUCLEAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Profiler 2 is a device that is designed for use as a radiation scanning system that is used to measure beam data in radiotherapy departments for dose modeling in the treatment planning computer.
Device Description
Profiler 2 is only used by the radiation therapy professionals, and is not used with the patient. A standard commercial power converter converts the power from the wall outlet voltage (100 to 240 VAC) to 18 VDC. The converter is then connected to a power/data interface (PDI) and then supplies the 18 VDC power to the Profiler 2 through a single 8 pin DIN connector. A standard 9 pin serial connectors connects the PDI to a computer. The commercial power converter and PDI device are fully tested for safety. Therefore, Profiler 2 should not generate a shock hazard to the operator.
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K Number
K051921Device Name
THE EDGE DETECTOR, MODEL 1118
Manufacturer
SUN NUCLEAR CORP.
Date Cleared
2005-07-27
(12 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
SUN NUCLEAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Edge™ Detector is a device that is designed for use as a radiation scanning detector in any water tank scanning system that is used to measure beam data in radiotherapy departments for dose modeling in the treatment planning computer.
Device Description
The Edge™ detector is a radiation hardened silicon diode. The diode is encapsulated in a rectangular housing made of thin brass sheet. The active dimension of The Edge™ detector is 0.8 x 0.8 mm2. The diode die plane is parallel with the long axis of the detector housing with the center of the die marked by the cross on the top surface. The detector is mounted such that its top surface is parallel to the water surface and perpendicular to the incident radiation beam axis. The Edge™ detector is water-proof.
The Edge™ detector is designed to measure the radiation distribution in a water phantom. Because of its very small active dimension, The Edge™ detector can measure small field beam parameters, such as penumbra and flatness, more accurately than the conventional ionization chamber with larger active dimensions. Therefore, The Edge™ detector is especially useful for beam modeling in radiation therapy techniques involving small field sizes, such as IMRT (Intensity Modulation Radiation Therapy).
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K Number
K013689Device Name
RE-ENTRANT CHAMBER
Manufacturer
SUN NUCLEAR CORP.
Date Cleared
2002-07-02
(238 days)
Product Code
KPT
Regulation Number
892.1360Why did this record match?
Applicant Name (Manufacturer) :
SUN NUCLEAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Model 1008 (44D as marketed under CNMC) is a well-type, re-entrant ionization chamber intended for measurement of source strength of both clinical HDR and LDR brachytherapy sources and intravascular brachytherapy (IVB) sources. Both types of IVB sources can be measured; those designed to deliver a gamma dose and those designed to deliver a beta dose. The chamber must be calibrated before any measurement of a clinical source takes place. Source strength calculation must be done with the accompanying calibration certificate from the calibration laboratory. The calibration must be performed by an accredited dosimetry calibration laboratory, with the same source type and isotope that is used clinically. The chamber constancy must be monitored after calibration with a proper Measurement Quality Assurance program in order to validate the chamber calibration over a period of time.
Device Description
The Model 1008 / Model 44D is a well-type re-entrant ionization chamber designed for application with brachytherapy and intravascular brachyterapy source measurement. The chamber is hermetically sealed, there is no air density correction requirement. The fill gas is pure argon at an absolute pressure of 23.5 psi, which provides several distinct benefits. These include enhancing the response at low photon energies from both gamma and Bremsstahlung from beta radiation. higher ion collection efficiency and long term constancy measurements. The Model 1008/44D is fully guarded into the chamber and is equipped with a 1.5 meter low-noise triaxial signal cable terminated with a triaxial collection electrode inside the chamber. When properly connected to a dosimetry electrometer, the chamber housing will be common to the electrometer housing: the collection electrode will be floating with the guard at the chamber bias potential. Therefore, no shock hazard should exist.
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K Number
K021463Device Name
MODEL 1133 IVD PC VERSION
Manufacturer
SUN NUCLEAR CORP.
Date Cleared
2002-06-06
(30 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
SUN NUCLEAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PC Version of the IVD Model 1133 has the same Indications for Use as the rf IVD submitted under K011332 which is quoted here: Sun Nuclear's Model 1133 rf-IVD is a battery operated dosimetry system designed to measure the patient's dose during radiation therapy treatment.
Device Description
The Sun Nuclear Model 1133 rf-IVD (In-Vivo Dosimetry) is a system that measures the radiation output of a linear accelerator or a radioactive substance such as a Co-60 source, during the treatment of a patient. It has 3 detector inputs per detector pod, with only one detector pod usable at a time. The radiation therapist connects the radiation detectors (diodes) to the Detector Module and then positions them on the patient in order to measure the radiation from the accelerator. The Detector Module communicates with the Base Station by radio frequency communication. The measurement data is then sent through a line to an optically isolated interface, then to the PC. The Detector Module and Base Station are battery powered. The therapist leaves the treatment room. Dose measurement is then remotely started on the rf-IVD from the control room using the PC Software and then the radiation beam is turned on. When the beam turns off, the rf-IVD is stopped and the dose value is displayed. The rf-IVD display value is recorded or printed on an accessory printer. The therapist then enters the room and removes the detector from the patient.
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K Number
K011332Device Name
RF-IVD WIRELESS DOSIMETER-MODEL 1133
Manufacturer
SUN NUCLEAR CORP.
Date Cleared
2001-07-26
(85 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
SUN NUCLEAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K011466Device Name
QED DIODE DETECTORS, MODELS 1112-1116
Manufacturer
SUN NUCLEAR CORP.
Date Cleared
2001-06-06
(23 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
SUN NUCLEAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K010449Device Name
IVD (IN VIVO DOSIMETER), MODEL 1131
Manufacturer
SUN NUCLEAR CORP.
Date Cleared
2001-05-04
(78 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
SUN NUCLEAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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