Australia - English - Department of Health (Therapeutic Goods Administration)

bk medical australia pty ltd - 60724 - medical image management system application software - mim symphony dx lite software is intended for trained medical professionals including, but not limited to, radiologists, oncologists, physicians and medical technologists. mim symphony dx lite software is a medical image and information management system that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, as well as create, display and print reports from those images. the medical modalities of these medical imaging systems include, but are not limited to, ct, mri, cr, dx, mg, us, spect, pet and xa as supported by acr/nema dicom 3.0. mim symphony dx lite software provides the user with the means to display, register and fuse medical images from multiple modalities. mim dx light software provides tools to quickly create, transform, and modify contours, transferring contours and archiving contours for patient follow- up and management.

Australia - English - Department of Health (Therapeutic Goods Administration)

bk medical australia pty ltd - 66195 - ultrasound imaging transducer cover connector - a device intended to protect the transducer and improve image quality by reducing image artifacts and air bubbles.

Australia - English - Department of Health (Therapeutic Goods Administration)

bk medical australia pty ltd - 45018 - non-implantable needle guide, single-use - an instrument designed to lead a needle into its proper course when performing ultrasound-guided punctures, biopsies and nerve blocks.

Australia - English - Department of Health (Therapeutic Goods Administration)

bk medical australia pty ltd - 64396 - intracorporal ultrasound transducer contouring attachment - intended to be used with a hand-held ultrasound imaging system transducer to provide means to replace the position of a needle guide.

Australia - English - Department of Health (Therapeutic Goods Administration)

bk medical australia pty ltd - 61587 - radiography digital imaging system remote control - a wireless hand-operated electronic unit with a configuration of analogue or digital push buttons designed to allow the user to operate features & functions with the console.

Australia - English - Department of Health (Therapeutic Goods Administration)

bk medical australia pty ltd - 36336 - remote control, foot-switch - an active device intended to be used with ultrasound scanners to allow the operator hands free use of certain functions. it is powered by low voltage and is connected to the usb port at the scanner.

Australia - English - Department of Health (Therapeutic Goods Administration)

bk medical australia pty ltd - 13730 - sterilization container - a container used to organize, protect and allow sterilization of medical devices.

Australia - English - Department of Health (Therapeutic Goods Administration)

vela diagnostics australia pty ltd - ct758 - bk virus ivds - the sentosa sa bkv quantitative pcr test is a real-time pcr-based in vitro diagnostic test intended for use in the detection and quantitation of bk virus (bkv) dna using sentosa sx101 instrument in conjunction with the rotor-gene? q mdx 5plex hrm instrument. for human edta plasma, serum and urine samples, sentosa sx virus total nucleic acid kit v2.0 is used for dna extraction; and for human edta whole blood samples, sentosa? sx whole blood kit is used for dna extraction.

Australia - English - Department of Health (Therapeutic Goods Administration)

biomerieux australia pty ltd - ct758 - bk virus ivds - bk virus test kit ivds

Australia - English - Department of Health (Therapeutic Goods Administration)

bk medical australia pty ltd - 40761 - ultrasound system, imaging, general-purpose - the bk fusion kit contains the necessary software and accessories to enable fusion of the mri and ultrasound images. the resultant images may be used to create, transform, modify and archive contours for patient follow-up and management.