Public Enquiry - Singapore Medical Device Register (SMDR)
Device Info
Device Name: Perceptra Inspectra CXR [Perceptra Co., Ltd.]
Description: Inspectra CXR is an AI-based software that analyzes adult frontal chest x-rays for signs of abnormalities in order to prioritize them for clinical review. Inspectra CXR identifies features suggestive of 8 abnormality conditions: 1.Pleural effusion 2.Tuberculosis 3.Lung opacity 4.Pulmonary edema 5.Mass 6.Nodule 7.Cardiomegaly 8.Atelectasis Inspectra CXR aids radiologists or trained clinicians in the analysis of adult frontal chest x-rays by providing notifications for worklist prioritization and triage. It identifies cases with suspected findings and provides a structured report and secondary capture image through PACS or MyInspectra web application. The device operates in parallel to and independent of standard of care image interpretation workflow. The device is intended as a notification-only tool and does not intend to replace the review of qualified physicians. Its results are not intended to be used to confirm clinical diagnosis or rule out possibility of specific diagnosis.
Medical Specialty Area: Radiology / Imaging
Medical Device Class: Class B medical device
Device Registration No: DE0509231
Registration Date: 25/04/2024
Change Notification Approval Date: Not Applicable
 
Product Owner
1. Perceptra Co., Ltd.  [Perceptra Co., Ltd.] 723 Supakam Bld., Charoen Nakhon,, Klongtonsai, Klongsan,, Bangkok 10600...
Registrant
1. YNL 360 Pte Ltd  380 JALAN BESAR, ARC 380, #13-06, SINGAPORE 209000
Models
No. Model Name Identifier UDI-DI DM-DI Place of Manufacture
1Inspectra CXR02.02.01THAILAND
 
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.