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PYLARIFY AI is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging, using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis.
Exini Diagnostics AB
02
In Commercial Distribution
- 07350002336021 ()
602
- Radiology DICOM image processing application software
PYLARIFY AI is a software only medical device that provides quantitative assessments of standardized uptake values (SUVs) for patients that are subject to examination by nuclear medicine (NM) imaging, using PSMA PET/CT, within the clinical application of oncology. The device performs by automatic organ and bone segmentation and lesions, selected by the user, will automatically be calculated into a lesion index (LI) and intensity-weighted total lesion volume (ITLV). The user of this product is typically a health-care professional using the software to review patient images and analyze results.
Exini Diagnostics AB
01
Not in Commercial Distribution
- 07350002336014 ()
601
- Radiology DICOM image processing application software
No Description
RICOH COMPANY,LTD.
RICOH160-1
In Commercial Distribution
- 04961311926266 ()
- Magnetoencephalography system, superconducting
MaxFilter™ is used with Elekta Neuromag®, Elekta Neuromag® TRIUX and TRIUXTM neo in suppressing magnetic interference and in reducing measurement artifacts.
Megin Oy
SW24051N
In Commercial Distribution
- 06430056480039 ()
- Magnetoencephalography system, superconducting
TRIUX™ neo non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electro-encephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain when used in conjunction with evoked response stimulators. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning.
TRIUX™ neo may be used for patients of all ages as appropriate for magnetoencephalography.
Megin Oy
NM27000N
In Commercial Distribution
- 06430056480411 ()
- Magnetoencephalography system, superconducting
MEGreview™ is used for detection and localization of epileptic spontaneous brain activity. In addition, MEGreview™ may be used for localization of eloquent cortex,
such as visual, auditory, somatosensory, and motor functions. Results interpreted by a trained clinician in conjunction with other imaging modalities can contribute to presurgical evaluation. MEGreview™ is intended for patients of all ages as appropriate for magnetoencephalography.
Megin Oy
SW26241N
In Commercial Distribution
- 06430056480404 ()
- Magnetoencephalography system, superconducting
Magnetoencephalography system (MEG), 275 channel
CTF MEG International Services Limited Partnership
CTF MEG 275
In Commercial Distribution
- B956CO0275110 ()
CO-0275-1-1
- Magnetoencephalography system, superconducting
5F Percutaneous Micro-Introducer Kit
ARGON MEDICAL DEVICES, INC.
497817
Not in Commercial Distribution
- 10886333215062 ()
- 00886333215065 ()
- 20886333215069 ()
- 5F
497817
- Magnetocardiography system
4F Percutaneous Micro-Introducer Kit
ARGON MEDICAL DEVICES, INC.
497816
Not in Commercial Distribution
- 10886333215055 ()
- 00886333215058 ()
- 20886333215052 ()
- 4F
497816
- Magnetocardiography system
5F Percutaneous Micro-Introducer Kit
ARGON MEDICAL DEVICES, INC.
497814
Not in Commercial Distribution
- 10886333215048 ()
- 00886333215041 ()
- 20886333215045 ()
- 5F
497814
- Magnetocardiography system