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Found 7 results
510(k) Data Aggregation
K Number
K010509Device Name
CEDARS-SINAI BPGS AND MOCO
Manufacturer
SMV AMERICA
Date Cleared
2001-04-27
(65 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
SMV AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003358Device Name
QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)
Manufacturer
SMV AMERICA
Date Cleared
2001-01-19
(85 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
SMV AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002553Device Name
DS DS I-SERIES
Manufacturer
SMV AMERICA
Date Cleared
2000-09-15
(29 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
SMV AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001681Device Name
POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM
Manufacturer
SMV AMERICA
Date Cleared
2000-08-25
(85 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
SMV AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991565Device Name
TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN S
Manufacturer
SMV AMERICA
Date Cleared
1999-08-02
(89 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
SMV AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SMV TAC-2 accessory to the SMV dual head emission tomographic systems produces images of a patient's anatomy when performing cardiac or wholebody imaging in single photon mode, or in coincidence mode (using the VCR option) . The system is intended to provide an enhancement to the emission images by compensating for the attenuation effects of the human body.
Device Description
The TAC-2 hardware consists of two sliding line source emitter block/collimator assemblies. Each assembly extends transaxially across the face of each detector of a DST series gamma camera oriented 180°. When in use each emitter block exposes the collimator in the opposing assembly. The assemblies travel in synchrony along the axial direction.
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K Number
K972686Device Name
VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER
Manufacturer
SMV AMERICA
Date Cleared
1997-10-14
(89 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
SMV AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VCAR option to the DST Gamma Camera and VISION Powerstation and the VCAR option to the DST-XL Gamma Camera and VISION Powerstation produce images which depict the anatomical distribution of radioisotopes within the human body, for interpretation by medical clinicians. The systems are intended for whole body nuclear imaging.
Indication for use of the VCR option to the DST and DST-XL cameras and Powerstation computer is an accessory upgrade intended to perform electronic collimation for coincidence imaging of positron-emitting radioisotopes in the human body.
Device Description
The VCAR option to the DST Gamma Camera and VISION Powerstation (DST&PS/VCAR) and the VCAR option to the DST-XL Gamma Camera and VISION Powerstation are accessory upgrades to the previously cleared DST an DST-XL Gamma Cameras (K921008) and VISION Powerstation (K912753). This accessory enables the system to perform electronic collimation for positron emission tomography (PET) of radioisotopes within the human body. The DST&PS/VCAR and DST-XL&PS/VCAR utilize proprietary coincidence detection electronics and software to perform electronic collimation of gamma rays emitted from decay of radioisotopes in a patient. This process is called "Coincident Photon Emission Computed Tomography" (CPECT).
The DST&PS/VCAR and DST-XL&PS/VCAR allows the operator to acquire coincidence imaging data by controlling the detector electronics and processors in coincidence imaging mode. The DST&PS/VCAR and DST-XL&PS/VCAR also includes the control, processing, and display screens to perform reconstruction of 2-D and 3-D information from the acquired datasets.
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K Number
K963273Device Name
VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION
Manufacturer
SMV AMERICA
Date Cleared
1997-03-11
(203 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
SMV AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VCAR option to the VISION FX-80 Gamma Camera and Power Station produces images which depict the anatomical distribution of radioisotopes within the human body, for interpretation by medical clinicians. The system is intended for whole body nuclear imaging.
Device Description
The VCAR option to the VISION FX-80 Gamma Camera and Power Station (FX-80&PS/VCAR) is an accessory upgrade to the previously cleared FX-80 Gamma Camera (K935273) and Power Station (K912753). This accessory enables the system to perform electronic collimation for positron emission tomography (PET) of radioisotopes within the human body. The FX-80&PS/VCAR utilizes proprietary coincidence detection electronics and software to perform electronic collimation of gamma rays emitted from decay of radioisotopes in a patient. This process is called "Coincident Photon Emission Computed Tomography" (CPECT). The FX-80&PS/VCAR allows the operator to acquire coincidence imaging data by controlling the detector electronics and processors in coincidence imaging mode. The FX-80&PS/VCAR also includes the control, processing, and display screens to perform reconstruction of 2-D and 3-D information from the acquired datasets.
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