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

hologic (australia & new zealand) pty ltd - 47540 - soft-tissue biopsy needle, single-use - a sterile, slender, sharply-pointed metal tube designed to percutaneously obtain a specimen of soft tissue for histopathological examination.

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

emergo asia pacific pty ltd t/a emergo australia - 58290 - psychological assessment system application software - the device provides professionals with objective measurements of hyperactivity, impulsivity, and inattention to aid in the clinical assessment of adhd and in the evaluation of treatment interventions in patients with adhd. results should be interpreted by qualified professionals.

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

black dog institute - 58290 - psychological assessment system application software - a software application program intended to provide evidence-based mental health assessment, information, and psychological therapies for patients regarding their mental health conditions. the software is not intended for diagnosed or un-diagnosed serious mental health conditions. the software application is intended for adult patients who may benefit from self-guided activities.

Singapore - engelsk - HSA (Health Sciences Authority)

hologic singapore pte. ltd. - obstetrics & gynaecology - the thinprep® system is intended as a replacement for the conventional method of pap smear preparation for use in screening for the presence of atypical cells, cervical cancer, or its precursor lesions (low-grade squamous intraepithelial lesions, high-grade squamous intraepithelial lesions), as well as all other cytologic categories as defined by the bethesda system for reporting cervical/vaginal cytologic diagnoses.

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

hologic (australia & new zealand) pty ltd - 37089 - adaptor, light source - a connector that permits the connection of the devices that together deliver light to a work field from a light source.

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

hologic (australia & new zealand) pty ltd - 40701 - chair, diagnostic imaging, multi-modality - this device is intended as an accessory to a mammographic x-ray machine. this chair is intended to support the patient while an x-ray is being taken. the chair can also be positioned for other x-ray procedures.

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

hologic (australia & new zealand) pty ltd - 41141 - cushion, arm - this system is an arm cushion and a sling to support a patient's arm while having a mammogram. it is specifically intended to support lymphatic drainage in the arm post lymphodecomy.

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

hologic (australia & new zealand) pty ltd - 35156 - radio-frequency ablation system generator - this device is a rf generator intended to create lesions in soft tissue in gynaecological surgery.

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

hologic (australia & new zealand) pty ltd - 11964 - holder, patient, head, - this device is intended to be used with a mammographic x-ray system. it is intended to allow the patient to rest their head against the plate while the x-ray is being taken. it is also intended to keep the patient in-line with the x-ray machine.

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

hologic (australia & new zealand) pty ltd - 40794 - hyperthermia applicator, rf, intracorporeal - a device which is a component of a hyperthermia system that delivers the radio frequency (rf) energy used to produce a systemic or local heating effect. it is intended for use in uterine ablation.