Data / Medical devices / Australia / Medical Resale PTY Limited
Medical Resale PTY Limited: FDA-registered device maker in Caloundra QLD Queensland, Australia, 94 510(k) clearances
Medical Resale PTY Limited is registered with the FDA (registration 3011416394) in Caloundra QLD Queensland, Australia. It lists 25 device types. The FDA files 94 510(k) clearances under its listings, the newest dated September 19, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011416394
- Address
- 3/2 Otranto Avenue, Caloundra QLD Queensland, Australia, 4551
- Owner or operator
- Medical Resale PTY Limited (10047901)
- Roles
- Exporter to the US
- First device listed
- November 19, 2014
- Registered through
- 2027
- Brand names listed
- 10C-D probe, 11L-D probe, 2009 GE OEC 9900 Elite, 2010 GE Discovery 690 VCT, 2012 GE Healthcare OEC 9900 Elite 9 Standard C-Arm, 2019 Canon Aquilion Lightning 160, 2020 GE Optima XR240 Gen 2 ANZ 1, 2020 GE Optima XR240 Gen 2 ANZ 2 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 19, 2022 | K221638 | Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 | EOB | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| November 18, 2020 | K202233 | Venue Go | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| September 2, 2020 | K202216 | EPIQ Series Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| March 22, 2019 | K182186 | CMOS Video-Rhino-Laryngoscope System | EOB | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| November 9, 2018 | K182857 | EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| October 4, 2018 | K181240 | Rhino-Laryngo Fiberscope Olympus ENF-GP2 | EOB | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| September 6, 2018 | K182234 | Optima XR240amx | IZL | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| July 27, 2018 | K181485 | EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| February 1, 2018 | K173957 | ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 20, 2017 | K173578 | Biograph mCT Family of PET/CT Systems | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 1, 2017 | K170904 | Biograph Horizon PET/CT | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 7, 2017 | K162838 | Philips iCT CT System | JAK | Substantially Equivalent | Philips Medical Systems (Cleveland), Inc. | accessdata.fda.gov |
| February 2, 2017 | K170019 | Aquilion Lightning, TSX-036A/1, V8.4 | JAK | Substantially Equivalent | Toshibamedical Systems Corporation | accessdata.fda.gov |
| August 8, 2016 | K160743 | Philips Ingenuity CT | JAK | Substantially Equivalent | Philips Medical Systems (Cleveland), Inc. | accessdata.fda.gov |
| April 6, 2016 | K160807 | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| March 10, 2016 | K160078 | Vivid T8 | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound and Primary Care Diagnotics, L | accessdata.fda.gov |
| January 21, 2016 | K153402 | Discovery NM/CT 670 CZT | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 18, 2015 | K151028 | LOGIQ e | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| March 4, 2015 | K150087 | Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System | IYN | Substantially Equivalent | Ge Vingmed Ultrasound AS | accessdata.fda.gov |
| February 10, 2015 | K142472 | Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| October 23, 2014 | K142876 | ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 23, 2014 | K142603 | Stryker Precision HD Camera System | GCJ | Substantially Equivalent | Stryker Endoscopy | accessdata.fda.gov |
| October 10, 2014 | K142628 | Acuson SC2000 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medi Cal Solutions, Inc. | accessdata.fda.gov |
| September 9, 2014 | K142395 | SC2000 and ACUSON X300 Diagnostic Ultrasound Systems | IYO | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 5, 2014 | K141261 | LOGIQ S7 EXPERT, LOGIQ S7 PRO | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| April 10, 2014 | K131902 | PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) | FDS | Substantially Equivalent | Pentax Medical Company | accessdata.fda.gov |
| April 10, 2014 | K131028 | PENTAX VIDEO BRONCHOSCOPES (EB FAMILY) | EOQ | Substantially Equivalent | Pentax Medical Company | accessdata.fda.gov |
| April 9, 2014 | K131855 | PENTAX VIDEO COLONOSCOPES (EC FAMILY) | FDF | Substantially Equivalent | Pentax Medical Company | accessdata.fda.gov |
| March 21, 2014 | K133657 | DISCOVERY PET/CT 710 | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| February 12, 2014 | K133533 | LOGIQ E | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| December 24, 2013 | K133431 | VENUE 50 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 24, 2013 | K131937 | VOLUSON I/E | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 30, 2013 | K131576 | OPTIMA CT660 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 29, 2013 | K131780 | EVIS EXERA III VIDEO SYSTEM | FDF | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| August 26, 2013 | K131527 | LOGIQ S8 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 21, 2013 | K132304 | EPIQ DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| August 16, 2013 | K131634 | SYMBIA | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 10, 2013 | K122470 | PENTAX EPK-I5010 VIDEO PROCESSOR | PEA | Substantially Equivalent | Pentax Medical | accessdata.fda.gov |
| January 10, 2013 | K121959 | EVIS EXERA III VIDEO SYSTEM | EOQ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| January 2, 2013 | K122457 | GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS | OWB | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| December 21, 2012 | K123754 | CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| August 16, 2012 | K122234 | OEC 9900 ELITE | OWB | Substantially Equivalent | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | accessdata.fda.gov |
| July 26, 2012 | K112391 | FUJINON COLONOSCOPES | FDF | Substantially Equivalent | Fujinon, Inc. | accessdata.fda.gov |
| June 22, 2012 | K121699 | ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 12, 2012 | K120833 | DISCOVERY CT750 HD | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| April 6, 2012 | K120388 | INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM | OXO | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| February 16, 2012 | K112680 | EVIS EXERA III VIDEO SYSTEM | FDF | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| September 23, 2011 | K112122 | VENUE 40 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 1, 2011 | K112213 | VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| July 20, 2011 | K110227 | OPTIMA CT660 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| January 5, 2011 | K102379 | LTF-Y0009; MAJ-YOO41; XOEV-3D1 | GCJ | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| October 5, 2010 | K101874 | GE LOGIQ P6/P6 PRO | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| July 2, 2010 | K100584 | EVIS EXERAII 180 SYSTEM | NWB | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| February 1, 2010 | K093563 | IU22 ULTRASOUND SYSTEM AND TRANSDUCERS | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| October 9, 2009 | K092948 | APLIO MX SSA-780A, VERSION 1.0 | IYN | Substantially Equivalent | Toshiba America Medical Systems, In.C | accessdata.fda.gov |
| July 17, 2009 | K091536 | OPTIMA MR450W | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 18, 2009 | K090745 | ARTIS ZEE / ZEEGOS WITH SW VC14 | IZI | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| May 15, 2009 | K091295 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 | ITX | Substantially Equivalent | Toshiba America Medical Systems, In.C | accessdata.fda.gov |
| December 12, 2008 | K083504 | GE DISCOVERY NM/CT 570C | KPS | Substantially Equivalent | Ge Medical Systems F.I. Haifa | accessdata.fda.gov |
| October 8, 2008 | K082816 | GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| October 8, 2008 | K082761 | GE LIGHTSPEED 7.2 CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 22, 2008 | K081722 | YSIO | KPR | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 15, 2008 | K082185 | GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 | IYO | Substantially Equivalent | Ge Medical Systems Ultrasound and Primary Care Dia | accessdata.fda.gov |
| June 12, 2008 | K081496 | OPTIMA PET/CT 560 | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 2, 2008 | K081022 | SOMATOM DEFINITION, MODEL AS/AS+ | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 11, 2008 | K080927 | BRIGHTVIEW VCT IMAGING SYSTEM | KPS | Substantially Equivalent | Philips Medical Systems (Cleveland), Inc. | accessdata.fda.gov |
| October 29, 2007 | K072918 | MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00 | ITX | Substantially Equivalent | Toshibamedical Systems Corporation | accessdata.fda.gov |
| October 17, 2007 | K072797 | GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND | IYO | Substantially Equivalent | General Electric Co. | accessdata.fda.gov |
| August 22, 2007 | K062623 | AXIOM LUMINOS DRF | OWB | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 5, 2007 | K063803 | ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc., Ultrasound DI | accessdata.fda.gov |
| July 12, 2006 | K061817 | LIGHTSPEED 7.1 CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 16, 2005 | K053069 | SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) | IYN | Substantially Equivalent | Sonosite,Inc. | accessdata.fda.gov |
| October 13, 2005 | K051645 | EVIS EXERA 160A SYSTEM | NWB | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| October 7, 2005 | K052640 | GEMINI RAPTOR | KPS | Substantially Equivalent | Philips Medical Systems (Cleveland), Inc. | accessdata.fda.gov |
| September 27, 2005 | K052434 | HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA | KPS | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| September 21, 2005 | K052293 | GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| September 16, 2005 | K052412 | INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ | OWB | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 17, 2005 | K050559 | GE DISCOVERY VCT SYSTEM | KPS | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| March 11, 2005 | K050489 | INNOVA 2100 | OWB | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| January 6, 2005 | K043535 | HD11 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| October 4, 2004 | K042540 | PHILIPS IU22 ULTRASOUND SYSTEM | IYO | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| July 30, 2004 | K041949 | ALLURA XPER FD10 | IZI | Substantially Equivalent | Philips Medical Systems North America Co. | accessdata.fda.gov |
| July 21, 2004 | K041112 | MAGNETOM ESPREE SYSTEM | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 17, 2004 | K041476 | GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| October 21, 2003 | K032974 | GE LOGIQ 5 PRO OR EXPERT | IYN | Substantially Equivalent | General Electric Co. | accessdata.fda.gov |
| August 22, 2003 | K031637 | INNOVA 3100 | OWB | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| August 6, 2003 | K032281 | SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Toshiba America Medical Systems, In.C | accessdata.fda.gov |
| May 22, 2003 | K031469 | AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7 | JAK | Substantially Equivalent | Toshiba America Medical Systems, In.C | accessdata.fda.gov |
| March 13, 2003 | K030455 | BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| April 17, 2002 | K021049 | OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM | OWB | Substantially Equivalent | Ge Oec Medical Systems | accessdata.fda.gov |
| March 30, 2001 | K010721 | AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM | IZI | Substantially Equivalent | Siemens Medical Corp. | accessdata.fda.gov |
| August 23, 1999 | K991896 | MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA | KPS | Substantially Equivalent | Ge Medical Systems F.I. Haifa | accessdata.fda.gov |
| March 18, 1994 | K935234 | STRYKER ENDOSCOPIC VIDEO ACCESSORIES | GCJ | Substantially Equivalent | Stryker Endoscopy | accessdata.fda.gov |
| April 2, 1979 | K790071 | ENDOSCOPE AND ACCESSORIES | GCP | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
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Updated September 19, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.