Medical Resale PTY Limited

FDA Device Registration & Listing · Caloundra QLD Queensland, AU · Registration 3011416394

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011416394
FEI Number
3011416394
Entity Name
Medical Resale PTY Limited
City/State/Country
Caloundra QLD Queensland, AU
Establishment Address
3/2 Otranto Avenue, Caloundra QLD Queensland 4551, AU
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Medical Resale PTY Limited (Owner Number: 10047901)
Owner / Operator Contact Address
3/2 Otranto Avenue, Sunshine Coast, AU-QLD 4551, AU
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K133657
PMA Number
N/A

All Registered Proprietary Names

2020 GE Optima XR240 Gen 2 ANZ 1 2020 GE Optima XR240 Gen 2 ANZ 2 ENF-VH ENF-V3 Toshiba Ultrasound Probe Probe Gastroscopes, EG 2990 I PENTAX GE Discovery NM/CT 570C L15-7IO TRANSDUCER D2CWC STATIC TRANSDUCER C5-1 TRANSDUCER S5-1 TRANSDUCER L12-5 50MM TRANSDUCER C9-2 TRANSDUCER S8-3 TRANDUCER, COMPACT L12-5 50 TRANSDUCER L12-3 TRANSDUCER X6-1 TRANSDUCER L18-5 TRANSDUCER C10-3V TRANSDUCER C8-5 TRANSDUCER V6-2 TRANSDUCER C10-4EC TRANSDUCER TRANSDUCER L12-5 50 COMPACT GE Infinia 3/8" Hawkeye 4 GP3 SPECT/CT Voluson i/e Siemens Ultrasound Probes P5-1 probe Philips Brilliance iCT 256 Philips Epiq 7G Ultrasound equipment Hologic Insight Mini C-Arm GE Voluson S6 System GE BrightSpeed Elite CT GE OEC 9800 Mobile II GE ML6-15-D Ultrasound Probe Philips Transducer Biograph mCT 128 Toshiba Xario XG Fujinon Colonoscope Axiom Artis Processor – Pentax EPK-i Artis Zee Biplane Lightspeed VCT 64 Slice Olympus Endoscopy Hawkeye 1 GE Discovery VCT PET CT GE Probe COLONOSCOPES: EC3890 Fi2 PENTAX GE Probe Siemens YSIO Rad room EPIQ 7 Logiq P6 Allura FD10 rel 7/2 OEC 9900 Elite GE Discovery 690 GE Innova 2100 IG530 Siemens S2000 Ultrasound systems Siemens S2000 Probes RAB4-8-D probe RNA5-9-D probe Philips Brightview XCT GE Venue 40 S4-10-D probe L8-18I-D probe RIC5-9-D probe C2-6b-D probe S4-10-D transducer 3Sp-D probe 10C-D probe GE RIC5-9-D Ultrasound Probe 11L-D probe 6S-D probe M5S- D IC5-9-D Probe Vivid T8 R2 Performix 40 Plus tube housing Epiq 7C GE Optima 660 CT ML6-15 probe RAB2-6-RS probe GE Venue R2 ultrasound system GE 3T HDxt MRI Philips S5-1 GE Voluson E10 BT15 system with probes 3Sc-RS probe 6S-RS probe 4Z1C probe Evis Exera II L8-18i-RS probe STRYKER LIGHTSOURCE GE Optima 450W Siemens Acuson Probes Olympus 180 Endoscopy Equipment Toshiba Aplio MX Philips Ingenuity CT CLV-190 Laryngoscopy equipment Olympus endoscopy C2-9-D probe 8C probe 9L-D probe C1-6-D probe IC5-9 V NAV BRACKET Millennium MG Gamma Camera VF16-5 probe VF12-4 probe P4-2 probe C8F3 4D probe Siemens 1.5T Magnetom ESPREE MRI Sonosite ultrasound GE Discovery 690 PET CT GE Discovery 710

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2025-11-18
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2025-11-18
NWB Endoscope, Accessories, Narrow Band Spectrum Gastroenterology, Urology Class 2 876.1500 2023-02-21
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2023-02-21
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-02-05
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-02-05
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-02-05
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2014-12-18
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2014-12-18
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2014-12-18
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2015-01-14
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2026-02-06
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-12-30
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-12-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-12-30
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2017-07-31
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-01-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-01-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-01-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-12-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-12-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-12-29
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2015-12-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2023-05-09
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2023-08-03
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2023-08-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-08-03
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2021-02-23
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-12-21
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-12-21
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-12-21
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2016-09-07
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2019-01-21
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2019-01-21
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2019-01-21
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-12-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-12-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2014-12-10
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2014-12-10
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2014-12-10
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2023-03-22
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2023-03-22
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-01-15
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-01-15
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-01-15
FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2015-03-24
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2017-01-31
PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement Gastroenterology, Urology Class 2 876.1500 2015-01-14
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2015-10-27
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2015-09-17
NWB Endoscope, Accessories, Narrow Band Spectrum Gastroenterology, Urology Class 2 876.1500 2017-03-06
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2017-03-06
FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2017-03-06
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2016-09-19
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2016-02-04
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2016-02-04
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2014-12-10
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2014-12-10
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2014-12-10
FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2015-01-14
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2014-12-10
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2014-12-10
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2014-12-10
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2024-06-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-12-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-12-20
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-12-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-07-19
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-07-19
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-07-19
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2016-07-19
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2023-06-28
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2023-06-28
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2023-06-28
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2018-08-12
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2014-12-10
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2014-12-10
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2016-06-24
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2016-06-24
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2016-06-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2017-04-05
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2017-04-05
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2017-04-05
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2017-04-05
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-12-30
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-12-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-12-30
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2019-06-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-01-15
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-12-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-12-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-12-20
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-01-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-01-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-01-29
ITY Assembly, Tube Housing, X-Ray, Diagnostic Radiology Class 1 892.1760 2025-04-16
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-04-21
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2023-04-21
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2023-04-21
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2023-04-21
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2017-01-03
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-12-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-12-30
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-12-30
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-12-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-12-30
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-12-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-09-23
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-09-23
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-09-23
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2017-02-19
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-03-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-03-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-03-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-12-21
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-12-21
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-12-21
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-12-30
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-12-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-12-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-01-03
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2019-01-03
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2019-01-03
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-01-03
FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2015-03-12
NWB Endoscope, Accessories, Narrow Band Spectrum Gastroenterology, Urology Class 2 876.1500 2015-03-12
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2015-03-12
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-12-30
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-12-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-12-30
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-09-01
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2018-07-02
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-11-07
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-11-07
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-11-07
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2014-12-23
FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2014-12-23
NWB Endoscope, Accessories, Narrow Band Spectrum Gastroenterology, Urology Class 2 876.1500 2014-12-23
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-01-15
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-01-15
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-01-15
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2019-04-03
NWB Endoscope, Accessories, Narrow Band Spectrum Gastroenterology, Urology Class 2 876.1500 2023-02-21
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2023-02-21
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2023-02-16
FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2022-09-30
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-12-30
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-12-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-12-30
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2017-08-22
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-01-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-01-03
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2019-01-03
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2017-05-25
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2017-05-25
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-10-16
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-10-16
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-10-16
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2023-06-28

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Medical Resale PTY Limited
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

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Related Recall Records

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Z-0031-2007 AGFA Corp. 2
CR DX-S, Image Intensified Fluoroscopic X-ray system.
Z-1470-2023 FUJIFILM Healthcare Americas Corporation 2
FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Z-3158-2024 FUJIFILM Healthcare Americas Corporation 2
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
Z-0003-2011 Verathon, Inc. 2
BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011416394. Last updated year: 2026. Please use registration number 3011416394 when referencing this establishment in official correspondence.
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