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

getz healthcare pty ltd - 57812 - radiology dicom image processing application software - subtlepet is an image processing software intended for use by radiologists and nuclear medicine physicians for transfer, storage, and noise reduction of fluorodeoxyglucose (fdg), amyloid, 18f-dopa, 18f-choline, 18f-dcfpyl, ga-68 dotatate, and ga-68 psma radiotracer pet images (including pet/ct and pet/mri).

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

device technologies australia pty ltd -

Singapore - English - HSA (Health Sciences Authority)

baxter healthcare (asia) pte ltd - cardiovascular - intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies, which include: defects of the abdominal and thoracis wall, hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical) and intracardiac and great vessel repair.

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

compumedics limited - 47541 - bioelectrical signal processing application software - xegis software is explicitly designed to help physicians in recording, archiving and reviewing data coming from xegis digital acquisition systems. xegis software can be used for emg and ep exams and other neurophysiological studies based on the data recorded from the patient through xegis acquisition devices. some analysis functional tools are provided as default or software options. results coming from these tools must never substitute the critical interpretation and the clinical conclusions that pertain to the physician only. xegis software is not intended to continuously monitor the central nervous system functionality, in conditions where a warning on the change of patient condition is essential (e.g. or and icu automatic monitoring without the presence of the physician), since it is not endowed with proper alarms that substitute continuous medical surveillance. the use of xegis software must always be carried out under the supervision of a physician or a qualified technician.

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

medical technologies aust pty ltd - 34540 - light source/processing unit, endoscope - cellvizio? and cellvizio? 100 series when used with confocal miniprobes are intended to allow confocal laser imaging of the internal microstructure of tissues in anatomical tracts, i.e. gastrointestinal or respiratory or urinary, accessed through an endoscope or endoscopic accessories.

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

baxter healthcare pty ltd - 33888 - dialyser reprocessing system - designed to be used as a protective barrier to help prevent contamination of the blood tubing fluid pathway.

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

fresenius medical care australia pty ltd - 33888 - dialyser reprocessing system - detects fluid loss at the fistula needle's access point on the vascular access arm of the patient. in the case of fluid loss, an audible alarm sounds to alert the patient.

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

inline systems pty ltd - 34540 - light source/processing unit, endoscope - camera with integrated light source to produce video from endoscopic inspections

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

pacific endoscopic imaging pty ltd - 34540 - light source/processing unit, endoscope - dr highscope hd is used to photograph specific parts of the human body with light from the light source.

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

miltenyi biotec australia pty limited - 60112 - magnetic cell separation system processing unit - the clinimacs? instruments are used for the in vitro separation of human cells from heterogeneous hematologic cell populations in combination with the clinimacs? system.