PAROS

Nom de l'organisation

INCEPTO MEDICAL SAS

SRN

FR-MF-000007545

Statut du fabricant

Actif

9 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW999

  PAROS is not intended to be used for: • Patients with complete prostatectomy history. • Patients with artifacts affecting interpretation of the prostate area. • Patients with endorectal coil (ERC). • Patients with prostate malformation or rare prostate pathologies. • Patients who have undergone radiotherapy or focal treatment of the prostate.
• CW999

  All MR exams must contain appropriate DICOM fields and it is the user's responsibility to ensure that DICOM fields are properly filled for the software to function properly and accurately.
• CW999

  Results shall not be used without clinician supervision. Users must not rely entirely on PAROS results but systematically analyze the images. Users must know that PAROS does not detect all anomalies and has a sensitivity and specificity inferior to 100% (risks of false positives and false negatives). Measurements shall be systematically confirmed by the clinician.
• CW999

  Input images shall: • Contain the entire prostate area, • Be at a level that would be interpretable by a radiologist.
• CW999

  Metal artifacts may impact performances of the software.
• CW999

  in case of images not meeting inclusion criteria or meeting exclusion criteria or in case of exams not containing required input images: no algorithmic prediction will be provided.
• CW999

  PAROS triage information shall not be used for diagnosis and images shall always be opened by the user.
• CW999

  Maintenance and installation operations shall be done by authorized personnel only.
• CW999

  Only axial acquisition images with limited obliquity shall be accepted.

Marché principal en France ; disponible dans 9 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

03760332080022

Basic UDI-DI

376033208PAROSA6

Numéro de référence/catalogue

PAROS

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Decision support software for medical imaging

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z11069092VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel