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510(k) Data Aggregation
K Number
K051947Device Name
RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE
Manufacturer
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
Date Cleared
2005-08-22
(35 days)
Product Code
LFL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CUSA Excel Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g.: bone) tissue is desirable, including Neurosurgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery and Thoracoscopic Surgery.
Device Description
The CUSA Excel Ultrasonic Surgical Aspirator System (CUSA) is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The CUSA Excel System consists of a console which provides control and power functions, a surgical handpiece which provides ultrasonic mechanical energy, a titanium handpiece tip and flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). A tip has been added to the CUSA Excel system to enable it to abrade bone. Testing was completed to demonstrate that the tip will abrade bone. The tip is manufactured from the same materials as in the other CUSA Excel tips.
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K Number
K041997Device Name
RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE
Manufacturer
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
Date Cleared
2004-08-27
(32 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
XKnife RT 3 with Non-Stereotactic Module is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic, collimated beam, computer planned, LINAC based treatment.
Device Description
The device is a module of the XKnife RT system that allows radiotherapy treatment planning using non-stereotactic CT image sets. As in traditional radiation treatment planning, external fiducial markers (rather than a stereotactic frame) now provide a reference from which an isocenter may be specified.
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K Number
K032054Device Name
RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE
Manufacturer
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
Date Cleared
2003-09-15
(75 days)
Product Code
HAW
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Radionics Nashold Biopsy Needle is intended for single patient use in stereotactic biopsy of brain tumors.
Device Description
The NBN-D is a dual cannula device made from stainless steel hypodermic needles. The device requires suction provided by a syringe to draw the tissue into the needle. The inner cannula is then rotated to cut the tissue. The device is designed to be used with the Radionics CRW system.
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K Number
K023519Device Name
RADIONICS VARILINK 2
Manufacturer
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
Date Cleared
2003-01-16
(87 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VariLink 2 MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. With Radionics' Treatment Planning Software, the MMLC enables static conformal treatments to be performed with finely shaped field patterns. The Varilink 2 MMLC can be used as part of IMRT (Intensity Modulated Radiotherapy) or general conformal radiation.
Device Description
The device is an optional accessory for the Radionics Mini-Multileaf Collimator (MMLC), mounted on a Varian C-Series Linear Accelerator (Linac). VariLink 2 allows Intensity Modulation Radiation Therapy (IMRT) functionality to be used on a Varian Linac. The Radionics' Treatment Planning software generates treatment plans with segmented beams, in which the intensity within the irradiation field is not constant (as in conventional treatments) but varies across the field. This requires the LINAC to suspend the beam between segments to allow the MMLC to change fields. VariLink 2 uses the Varian gating board to suspend the beam to allow MMLC to change the shape of the field.
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K Number
K021942Device Name
RADIONICS POLE NEEDLES
Manufacturer
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
Date Cleared
2002-09-11
(90 days)
Product Code
GXI
Regulation Number
882.4725Why did this record match?
Applicant Name (Manufacturer) :
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A Pole Needle is an injection needle, which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. The nerve is localized either by using electrical stimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic or a radiofrequency lesion may be made.
Device Description
There are four types of needles: SMK Sluijter-Mehta Cannulae, RF Pole, Pole and Flexible Needles.
SMK Cannulae is used in radiofrequency (RF) lesion procedures for the relief of pain. The device allows a injection of local anesthetic to relieve the pain of RF. A SMK-TC electrode is then placed into the cannulae to create the lesion. The length of the cannula is insulated except for a section of the tip. The RF energy is then transferred from the electrode through this uninsulated portion which heats the surrounding tissue to create a lesion.
RF Pole is used for percutaneous facet denervations. The device consists of a shaft of hypodermic tubing which is insulated except for 5mm at the tip. Plastic tubing and an electrical lead are unitized in a single flexible leader portion which connects to the shaft. The lead is insulated and feed through the plastic tube. A Luer hub on the tubing allows injection of local anesthetic. The needle can be connected to a Radionics generator for stimulation and lesioning. The RF pole does not allow for temperature monitoring.
Pole is used for percutaneous stimulation and injection. The design of the pole is similar to the RF pole except for the exposed tip. Only the beveled surface, 1mm, is uninsulated. The pole is intended to be connected to a stimulus generator.
Flexible Injection Needle is used for prognostic block injections of local anesthetics or injection of contrast media. The device consists of hypodermic tubing attached to PVC tubing. The needle has no electrical connection. The tubing has a Luer hub to allow the injection with a syringe at a more remote position from the needles field.
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K Number
K013661Device Name
XPLAN 2.2 WITH THE BODY SYSTEM
Manufacturer
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
Date Cleared
2001-12-03
(27 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
XPlan 2.2 software is a stereotactic LINAC-based ration treatment planning system. XPlan 2.2 with the Body System localizes lesions to be treated using CT scans, MR scans, and digitized anglographic film. XPlan 2.2 with the Body System provides stereotactic planning system for treatment of tumors. The conformal stereotactic radiation therapy treatments are delivered over multiple fractions.
Device Description
The above system consists of stereotactic treatment planning software and hardware to immobilize and localize the patient.
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K Number
K012850Device Name
RECORDING AND STIMULATING ELECTRODE
Manufacturer
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
Date Cleared
2001-11-19
(87 days)
Product Code
GZL, GYC
Regulation Number
882.1330Why did this record match?
Applicant Name (Manufacturer) :
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To record electrical activity or evoke a response through stimulation for the purpose of brain mapping during functional neurosurgical procedures.
Device Description
The Recording and Stimulating Electrode is a passive probe guided stereotactically to record electrical activity or evoke a response through stimulation for the purpose of brain mapping during foretional neurosurgical procedures.
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K Number
K010548Device Name
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
Manufacturer
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
Date Cleared
2001-03-12
(14 days)
Product Code
HAW
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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