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
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Medical Device Class: |
Class B medical device
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Device Registration No: |
DE0509231
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Registration Date: |
25/04/2024
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Change Notification Approval Date: |
Not Applicable
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1. Perceptra Co., Ltd.
[Perceptra Co., Ltd.] 723 Supakam Bld., Charoen Nakhon,, Klongtonsai, Klongsan,, Bangkok 10600...
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1. YNL 360 PTE LTD
101 CECIL STREET, TONG ENG BUILDING, #26-01/07, SINGAPORE 069533
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No. |
Model Name |
Identifier |
UDI-DI |
DM-DI |
Place of Manufacture |
1 | Inspectra CXR | 02.02.01 | | | THAILAND |
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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.
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