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510(k) Data Aggregation
K Number
DEN240018Device Name
CORIS System
Manufacturer
Nanosonics Limited
Date Cleared
2025-03-19
(322 days)
Product Code
FEB
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Nanosonics Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K241536Device Name
trophon Wireless Ultrasound Probe Holder
Manufacturer
Nanosonics Limited
Date Cleared
2024-09-27
(120 days)
Product Code
OUJ
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
Nanosonics Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The trophon Wireless Ultrasound Probe Holder is an accessory to be added to the trophon EPR and trophon2 to allow wireless ultrasound probes to be disinfected.
trophon EPR:
The trophon EPR is designed to provide High-Level Disinfection of ultrasound transducers. The system uses the trophon Disinfectant which is intended to be used exclusively with the trophon EPR device.
The trophon Disinfectant is intended for use as a High-Level Disinfectant to be used exclusively with the trophon EPR for the High-Level Disinfection of ultrasound transducers.
The trophon EPR is suitable for use in general hospital and health care facilities by trained personnel.
The trophon EPR system consists of a multiple use instrument combined with a single use disinfectant, delivered from a multi-dose cartridge.
The trophon Disinfectant should be used with the following contact conditions:
Minimum Operational Cycle Time: 7 minutes Minimum Concentration: 31.5% Minimum Disinfectant Dose: 1.0 g Minimum Chamber Temperature: 56℃
trophon2:
The trophon2 is designed to provide High-Level Disinfection (HLD) of validated ultrasound transducers. High-Level Disinfection is achieved by surface exposure to a controlled dose of hydrogen peroxide mist delivered to a disinfection chamber contain the ultrasound probe.
The trophon2 system consists of a multiple use instrument combined with a single use disinfectant "trophon Sonex-HL", delivered from a multi-dose cartridge.
The trophon2 is suitable for use in general hospital and health care facilities by trained personnel.
The trophon Sonex-HL should be used with the following contact conditions: Minimum Operational Cycle Time: 7 minutes Minimum Concentration: 31.5% Minimum Disinfectant Dose: 1.0 g Minimum Chamber Temperature: 56°C
Device Description
The trophon Wireless Ultrasound Probe Holder is an accessory to be added to the trophon EPR and trophon2 to allow wireless ultrasound probes to be disinfected.
The Nanosonics trophon EPR and trophon2 are software-controlled devices which provide High- Level Disinfection of ultrasound transducers. The device consists of a sealed disinfection chamber and operates in conjunction with a multi-dose cartridge of concentrated hydrogen peroxide disinfectant, supplied as an accessory to the device. Precleaned and dried ultrasound transducers are placed within the trophon EPR/trophon2 chamber and disinfected by means of an automated disinfection and aeration cycle. The disinfected ultrasound transducer is removed from the chamber and is ready for immediate use.
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K Number
K173865Device Name
trophon2
Manufacturer
Nanosonics Limited
Date Cleared
2018-04-24
(125 days)
Product Code
OUJ
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
Nanosonics Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The trophon2 is designed to provide High-Level Disinfection (HLD) of validated ultrasound probes. High-Level Disinfection is achieved by surface exposure to a controlled dose of hydrogen peroxide mist delivered to a disinfection chamber containing the ultrasound probe.
The trophon2 system consists of a multiple use instrument combined with a single use disinfectant "trophon Sonex-HL", delivered from a multi-dose cartridge.
The trophon2 is suitable for use in general hospital and health care facilities by trained personnel.
The trophon Sonex-HL should be used with the following contact conditions: Minimum Operational Cycle Time: 7 minutes Minimum Concentration: 31.5% Minimum Disinfectant Dose: 1.0 g Minimum Chamber Temperature: 56℃
Device Description
The trophon2 is a software controlled device which provides High-Level Disinfection of ultrasound transducers. The device consists of a sealed disinfection chamber and operates in conjunction with a multi-dose cartridge of concentrated hydrogen peroxide disinfectant "trophon Sonex- HL".
Pre-cleaned and dried ultrasound transducers are placed within the trophon2 chamber and disinfected by means of an automated disinfection and aeration cycle.
The disinfected ultrasound transducer is removed from the chamber, wiped and is ready for immediate use.
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K Number
K103126Device Name
TROPHON CHEMICAL INDICATOR
Manufacturer
NANOSONICS LIMITED
Date Cleared
2011-03-03
(132 days)
Product Code
JOJ, CLA
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
NANOSONICS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trophon Chemical Indicator is intended by Nanosonics for use by health care providers for confirming that the disinfectant delivered into the Chamber of the Nanosonics Trophon EPR disinfector device is above the minimum effective concentration (MEC) required to achieve the stated performance of the Trophon EPR.
The Trophon Chemical Indicator is used exclusively for monitoring the High Level Disinfection process when placed within the Trophon EPR chamber.
The color of the Trophon Chemical Indicator changes from red to yellow when exposed to hydrogen peroxide, the active ingredient in Trophon EPR-C40 disinfectant. This occurs above the minimum effective concentration (MEC) established for this solution.
Device Description
The device is a qualitative, single use, disc (26 mm in diameter) that has a hydrogen peroxide sensitive chemical indicating ink applied to a Tyvek substrate. The hydrogen peroxide sensitive chemical indicating ink has been designed to transition from an initial red color to a signal yellow color when subjected to sources of hydrogen peroxide.
Chemical indicator based on proprietary ink technology which changes color on exposure to sterilant.
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K Number
K103059Device Name
TROPHON
Manufacturer
NANOSONICS LIMITED
Date Cleared
2011-02-24
(132 days)
Product Code
OUJ
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
NANOSONICS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trophon EPR is designed to provide High-Level Disinfection of ultrasound transducers. The system uses the Trophon Disinfectant which is intended to be used exclusively with the Trophon EPR device.
The Trophon Disinfectant is intended for use as a High-Level Disinfectant to be used exclusively with the Trophon EPR for the High-Level Disinfection of ultrasound transducers.
The Trophon EPR is suitable for use in general hospital and health care facilities by trained personnel.
The Trophon EPR system consists of a multiple use instrument combined with a single use disinfectant, delivered from a multi-dose cartridge.
The Trophon Disinfectant should be used with the following contact conditions:
Minimum Operational Cycle Time: 7 minutes
Minimum Concentration: 31.5%
Minimum Disinfectant Dose: 1.0 g
Minimum Chamber Temperature: 56°C
Device Description
The Nanosonics Trophon EPR is a software controlled device which provides High-Level Disinfection of ultrasound transducers. The device consists of a sealed disinfection chamber and operates in conjunction with a multi-dose cartridge of concentrated hydrogen peroxide disinfectant, supplied as an accessory to the device. Pre-cleaned and dried ultrasound transducers are placed within the Trophon EPR chamber and disinfected by means of an automated disinfection and aeration cycle. The disinfected ultrasound transducer is removed from the chamber and is ready for immediate use.
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