Public Enquiry - Singapore Medical Device Register (SMDR)
Device Info
Device Name: Claritas HealthTech Claritas iPET [Claritas HealthTech Pte Ltd]
Description: Claritas iPET is an image processing software intended for use by radiologists and nuclear medicine physicians for noise reduction, sharpening, and resolution improvement of PET images (including PET/CT and PET/MRI) obtained with any kind of radionuclides, e.g. fluorodeoxyglucose (FDG). Enhanced images will be saved in DICOM files and exist in conjunction with original images.
Medical Specialty Area: Radiology / Imaging
Medical Device Class: Class B medical device
Device Registration No: DE0507340
Registration Date: 04/10/2022
Change Notification Approval Date: Not Applicable
 
Product Owner
1. Claritas HealthTech Pte Ltd  [Claritas HealthTech Pte Ltd] TANJONG PAGAR ROAD, #20-A, SINGAPORE 088443
Registrant
1. CLARITAS HEALTHTECH PTE LTD  20A TANJONG PAGAR ROAD, SINGAPORE 088443
Models
No. Model Name Identifier UDI-DI DM-DI Place of Manufacture
1Claritas iPETiPETSINGAPORE
 
Note: All device listings on the Singapore Medical Device Register (SMDR) are active. Class A medical devices are not registered in the SMDR. To retrieve Class A medical devices, please visit Class A Medical Device Database.