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qXR-LN

FDA UDI

Class II (US FDA UDI)

by Qure.ai Technologies Private Limited

Identity

Trade Name
qXR-LN FDA UDI
Generic Name
Radiology DICOM image processing application software FDA UDI
Device Name
The qXR-LN (qXR_Lung_nodule) is computer-aided detection software to identify and mark regions in relation to suspected pulmonary nodules from 6 to 30 mm in size. The device is intended to be used in the incidental adult population. It is designed to aid the physician to review the frontal (AP/PA) chest radiographs of adults acquired on digital radiographic systems as a second reader and be used with any DICOM viewer or PACS . qXR-LN provides adjunctive information only and is not a substitute for the original chest radiographic image FDA UDI
Model / Reference
1.0.0 FDA UDI
Description
The qXR-LN (qXR_Lung_nodule) is computer-aided detection software to identify and mark regions in relation to suspected pulmonary nodules from 6 to 30 mm in size. The device is intended to be used in the incidental adult population. It is designed to aid the physician to review the frontal (AP/PA) chest radiographs of adults acquired on digital radiographic systems as a second reader and be used with any DICOM viewer or PACS . qXR-LN provides adjunctive information only and is not a substitute for the original chest radiographic image FDA UDI

Identifiers

Primary DI / UDI-DI
00850057636024 FDA UDI
510(k) Number
K231805 FDA UDI
FDA Product Code
MYN FDA UDI
GMDN Term
Radiology DICOM image processing application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2070 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiology DICOM image processing application software

qXR-LN by Qure.ai Technologies Private Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology DICOM image processing application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Qure.ai Technologies Private Limited

Sources (1)

  • FDA UDI 00b85c60-52c9-4044-8868-b660b5aeb3cc 35 fields · synced May 30, 2026