Primary Device ID | 08800046800020 |
NIH Device Record Key | dd79392a-e14b-43b3-888d-809b33a76b4f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ClariPulmo |
Version Model Number | 2.0.1 |
Company DUNS | 693744312 |
Company Name | ClariPI Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08800046800020 [Primary] |
LLZ | System, Image Processing, Radiological |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-09-08 |
Device Publish Date | 2023-08-31 |
08800046800006 - ClariCT.AI | 2023-12-04 |
08800046800013 - ClariSIGMAM | 2023-09-08 ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. ClariSIGMAM calcu |
08800046800020 - ClariPulmo | 2023-09-08ClariPulmo is a non-invasive image analysis software for use with CT images which is intended to aid the assessment of lung Abnormalities. The software is designed to support the physician in quantification of physicianidentified lung Abnormalities. The software will provide automated segmentation of the lungs and quantification of low-attenuation and high-attenuation areas within the segmented lungs by using predefined Hounsfield unit thresholds. The software displays by color the segmented lungs and identified Abnormality. ClariPulmo provides optional denoising and kernel normalization functions for improved quantification of lung Abnormalities in cases when CT images were taken at low-dose conditions or with sharp reconstruction kernels. |
08800046800020 - ClariPulmo | 2023-09-08 ClariPulmo is a non-invasive image analysis software for use with CT images which is intended to aid the assessment of lung Abno |
08800046800136 - ClariCT.AI | 2023-09-06 ClariCT.AI, is a software device intended for networking, communication, processing and enhancement of CT images in DICOM format |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CLARIPULMO 88550920 not registered Live/Pending |
ClariPI Inc. 2019-07-30 |