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Found 3 results
510(k) Data Aggregation
K Number
K983401Device Name
FRAMEWAVE WEB
Manufacturer
ML STRATEGIES, INC.
Date Cleared
1998-12-15
(78 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ML STRATEGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Access Radiology "Framewave Web" Image and Information System is indicated for the display and management of radiologic images and associated information stored and transmitted in both compressed and uncompressed form.
Device Description
Not Found
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K Number
K973363Device Name
NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633
Manufacturer
ML STRATEGIES, INC.
Date Cleared
1998-07-02
(297 days)
Product Code
IWI
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
ML STRATEGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The North American Scientific Corporation's Pd-103 Radionuclide Brachytherapy Source is a device intended to deliver radiation by interstitial, intracavity or surface application for therapy of malignant lesions.
Device Description
Pd-103 Radionuclide Brachytherapy Source
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K Number
K972271Device Name
NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A
Manufacturer
ML STRATEGIES, INC.
Date Cleared
1997-10-28
(132 days)
Product Code
KXK
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
ML STRATEGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The North American Scientific Corporation's I-125 Radionuclide Brachytherapy Source Model MED3631-A is a device intended to deliver radiation by interstitial intracavity or surface application for therapy of malignant lesions.
Device Description
I-125 Radionuclide Brachytherapy Source Model MED3631-A
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