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Found 6 results
510(k) Data Aggregation
K Number
K063274Device Name
ACCULOC BREAST LOCALIZATION SYSTEM
Manufacturer
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC.
Date Cleared
2006-12-12
(43 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for use of ACCULOC Breast Localization System (formerly MAMMOLOC) are lesions requiring extracranial stereotactic radiotherapy or radiosurgery to the breast.
The software is used to determine the precise location of the target with respect to implanted fiducials.
Device Description
Not Found
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K Number
K012575Device Name
PREFERNCE IMRT TREATMENT PLANNING MODULE
Manufacturer
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC.
Date Cleared
2002-03-12
(215 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas.
The expanded indications for use are also applicable as previously presented for pReference Treatment System (K983793), including hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, and prostatic tumors.
The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target with respect to implanted fiducials, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.
Device Description
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K Number
K001833Device Name
PREFERENCE TREATMENT SYSTEM
Manufacturer
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC.
Date Cleared
2000-09-28
(104 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983793Device Name
PREFERENCE TREATMENT SYSTEM
Manufacturer
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC.
Date Cleared
1999-10-05
(343 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas.
- The indications for use of pReference Treatment System are expanded to include lesions requiring extracranial stereotactic radiotherapy or radiosurgery. These include hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, and prostatic tumors.
- The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target with respect to implanted fiducials, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.
Device Description
Not Found
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K Number
K970464Device Name
P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1
Manufacturer
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC.
Date Cleared
1997-09-05
(210 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for use of pReference Treatment Planning Software 1.1 are such intracranial diseases as gliomas, neuromas, meningiomas, astrocytomas, arteriovenous malformations, and metastatic carcinomas.
The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.
Device Description
Not Found
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K Number
K960293Device Name
MRTOFLM COMPUTER PROGRAM
Manufacturer
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC.
Date Cleared
1996-08-01
(198 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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