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510(k) Data Aggregation
K Number
K032135Device Name
SITE-RITE IV ULTRASOUND SYSTEM
Manufacturer
DYMAX CORP.
Date Cleared
2003-07-21
(10 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
DYMAX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Site~Rite IV Ultrasound System with associated probes and accessories provide ultrasound imaging of vascular structures, various organs, and structures of the body. Ultrasound guidance for placement of needles and catheters in these structures or organs may also be performed. The ultrasound guidance may occur either intraoperatively or percutaneously. The Site~Rite IV Ultrasound System is not intended for ophthalmic applications.
Device Description
The Site-Rite IV pulsed echo ultrasound system is a lightweight, lowoutput, portable, real-time, B-mode, ultrasound scanner designed primarily to assist clinicians in gaining vascular access to major veins, arteries and organs. It is a unique scanner that offers high resolution imaging to the depth of 18 cm. Site-Rite is portable and thus easy to use at the bedside and in a variety of clinical settings: intensive care units, emergency rooms, operating rooms, angiography suites, catheterization laboratories, etc. The Site-Rite IV ultrasound scanner can be operated on battery or AC power. It utilizes only proprietary probes manufactured and currently marketed by Dymax, with frequencies ranging from 3.5 MHz to 9.0 MHz. Image depth depends on the choice of probe and ranges from a minimum of 0.5 cm with the 9.0 MHz probe to a maximum of 18 cm with the 3.5 MHz probe. The disposable items, supplied in sterile packs, are currently marketed products.
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K Number
K993624Device Name
SITE-RITE 3 ULTRASOUND SYSTEM
Manufacturer
DYMAX CORP.
Date Cleared
1999-11-10
(15 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
DYMAX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Site-Rite 3 ultrasound system with associated probes and accessories provide ultrasound imaging of vascular structures, various organs, and structures of the body. Ultrasound guidance for placement of needles and catheters in these structures or organs may also be performed. The ultrasound guidance may occur either intraoperatively or percutaneously. The Site~Rite 3 is not intended for opthalmic applications.
Device Description
The Site-Rite 3 pulsed echo ultrasound system is a lightweight, lowoutput, portable, real-time, B-mode, ultrasound scanner designed primarily to assist physicians in gaining vascular access to major veins and arteries. It is a unique scanner that offers high resolution imaging to the depth of 18 cm. Site-Rite is portable and thus easy to use at the bedside and in a variety of clinical scenarios: intensive care units, emergency rooms, operating rooms, angiography suites, catheterization laboratories, etc. The Site-Rite 3 ultrasound scanner can be operated on battery or AC power. It utilizes only proprietary probes manufactured and currently marketed by Dymax, with frequencies ranging from 3.5 MHz to 9.0 MHz. Image depth depends on the choice of probe and ranges from a minimum of 0.5 cm with the 9.0 MHz probe to a maximum of 18 cm with the 3.5 MHz probe. The disposable items, supplied in sterile packs, are currently marketed products.
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