Ireland - English - HPRA (Health Products Regulatory Authority)

imaging equipment limited - mertiatide - kit for radiopharmaceutical preparation - 0.2 milligram - technetium (99mtc) compounds

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

united imaging healthcare (australia & new zealand) pty ltd - 45143 - combination diagnostic imaging system, pet/ct - a radiological imaging system that is a combination of a positron emission tomography (pet) camera system for nuclear medicine images, and a computed tomography (ct) camera system for x-ray images. the nuclear medicine images and the x-ray images may be registered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data. the pet and ct portions of the system may be used independently or in combination. the pet and ct images may be transferred to other systems for radiation therapy planning or additional processing.

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

imaging solutions pty ltd - 40652 - table, diagnostic imaging, - adjustable height c-arm table

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

australian imaging - 40849 - computer, diagnostic imaging system, x-ray, computed tomography - the line up is intended to be used for 3d imaging of the foot, ankle and knee regions, to visualise and assess the osseous and certain soft tissue structures, including joint spaces, bone angles and fractures. this modality is anticipated to be used when appropriate diagnosis of a given foot, ankle or knee condition is considered necessary.

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

australian imaging - 40849 - computer, diagnostic imaging system, x-ray, computed tomography - the inreach is intended to be used for 3d imaging of the hand and arm / extremity region, to visualise and assess the osseous and certain soft tissue structures, including joint spaces, bone angles and fractures. this modality is anticipated to be used when appropriate diagnosis of a given hand or arm condition is considered necessary.

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

united imaging healthcare (australia & new zealand) pty ltd - 40935 - workstation, diagnostic imaging, x-ray system - intended for the archiving, transmission, viewing, post-processing and filming of mammographic images.

Singapore - English - HSA (Health Sciences Authority)

ehc supply - radiology / imaging - is a dental x-ray system designed for imaging of tm joint studies, mandible & maxilla for implant planning, sinuses, and other areas of the maxillofacial complex.

Singapore - English - HSA (Health Sciences Authority)

sg medical imaging pte. ltd. - radiology / imaging - the dbis device is intended as an adjunct to mammogram for the diagnostic screening for detection of breast cancer. thermography devices should not be used for routine breast cancer screening or diagnosis, but may only be used as an adjunctive tool to mammography.

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

fresenius kabi australia pty ltd - 38371 - protection equipment, radiation, shielding material, magnetic field - protection accessory intended to encase infusion pumps to enable use within a magnetic resonance imaging unit. may also be used as a power source for these infusion pumps whilst within the mri unit.

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

siemens healthcare pty ltd - 45016 - spect/ct diagnostic imaging system - a radiological imaging system that is a combination of a single photon emission computed tomography (spect) camera system for nuclear medicine images, and a computed tomography (ct) camera system for x-ray images. the nuclear medicine images and the x-ray images may be registered and displayed in a fused format (overlaid in the same orientation)