Who is the manufacturer of qXR-CTR?

Qure.Ai Technologies filed the 510(k) submission for qXR-CTR (K231149).

What is the FDA product code for qXR-CTR?

QIH. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for qXR-CTR?

510(k) clearance (submission type: Traditional).

Does qXR-CTR use AI or machine learning?

Yes. qXR-CTR (K231149) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like qXR-CTR?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like qXR-CTR get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

qXR-CTR

K231149 · Qure.Ai Technologies · QIH · Sep 22, 2023 · Radiology

Device Facts

Record ID	K231149
Device Name	qXR-CTR
Applicant	Qure.Ai Technologies
Product Code	QIH · Radiology
Decision Date	Sep 22, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans. qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm. The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities. The system is suitable for adults ≥ 22 years of age. The device is used to aid the intended users and results are not intended to be used on a stand-alone basis for clinical decision making or otherwise preclude clinical assessment of CTR cases.

Device Story

qXR-CTR is a non-invasive software medical device for automated cardiothoracic ratio (CTR) assessment on PA chest X-rays. Input: DICOM PA chest X-ray images. Processing: AI algorithm measures maximal transverse heart diameter (CD) and maximal inner thoracic diameter (TD) to calculate CTR. Output: Structured report with CTR value, annotation lines, and preview image. Usage: Installed on hospital/clinic computers; operated by physicians or licensed practitioners. Workflow: Integrates into PACS or web-based environments; provides quantitative data to aid clinical assessment. Benefit: Assists clinicians in evaluating cardiac size; does not replace clinical judgment.

Clinical Evidence

Retrospective clinical study of 435 PA chest X-rays from US sites. Ground truth established by 3 ABR-certified thoracic radiologists (>10 years experience). Primary endpoints: RMSE and Mean Absolute Error (MAE) for cardiac and thoracic diameter measurements. Results: Cardiac diameter RMSE 7.55 mm (95% CI: 6.95, 8.34); Thoracic diameter RMSE 5.43 mm (95% CI: 4.95, 6.11). MAE (SD) for cardiac diameter: 5.66 (5.0) mm; for thoracic diameter: 4.04 (3.63) mm. Performance exceeded predicate device metrics.

Technological Characteristics

Software-only medical device; runs on off-the-shelf hardware (Ubuntu 20.04+). Uses deep-learning AI algorithm for image analysis. Inputs: DICOM PA chest X-rays. Outputs: Structured reports (PDF/JSON/DICOM SR). Connectivity: PACS integration or web-based download. No physical materials or energy sources.

Indications for Use

Indicated for adults ≥ 22 years of age for automated assessment of cardiothoracic ratio (CTR) on posterior-anterior (PA) chest X-rays in clinical settings. Not for stand-alone clinical decision-making.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System (K212624)

Related Devices

K212624 — EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System · Ever Fortune.Ai, Co., Ltd. · Apr 4, 2022
K232613 — CT Cardiomegaly · Innolitics, LLC · Feb 28, 2024
K240786 — AutoChamber · HeartLung Corporation · Oct 10, 2024
K243672 — CardIQ Suite · GE Medical Systems SCS · Jun 18, 2025
K203256 — Imbio RV/LV Software · Imbio, LLC · Mar 9, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue. Qure.ai Technologies % Srinidhi Ragunathan Regulatory Clinical Affairs Manager Level 7, Commerz II, International Business Park Oberoi Garden City, Goregaon(E) Mumbai, Maharashtra 400063 INDIA September 22, 2023 Re: K231149 Trade/Device Name: qXR-CTR Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: August 24, 2023 Received: August 24, 2023 Dear Srinidhi Ragunathan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jessica Lamb Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231149 Device Name qXR-CTR ## Indications for Use (Describe) qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans. qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm. The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities. The system is suitable for adults > 22 years of age. The device is used to aid the intended users and results are not intended to be used on a stand-alone basis for clinical decision making or otherwise preclude clinical assessment of CTR cases. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------|-----------------------------------------------| | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) SUMMARY ## Qure.ai's qXR-CTR #### 1 SUBMITTER Qure.ai Technologies Level 7, Commerz II, International Business Park Oberoi Garden City, Goregaon (E), Mumbai 400 063 Phone: +91-9768123013 Primary Contact Person: Srinidhi Ragunathan Secondary contact person: Bunty Kundnani Date Prepared: August 23, 2023 #### 2 DEVICE | Name of Device: | qXR-CTR | |-----------------------|--------------------------------------------------| | Common or Usual Name: | Automated radiological image processing software | | Classification Name: | Medical image management and processing system | | Regulatory Class: | Class II | | Regulation Number: | 21 CFR 892.2050 | | Product Code: | QIH | #### 3 PREDICATE DEVICE | Name of Device: | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | |-----------------|----------------------------------------------------------------| | Manufacturer: | Ever Fortune.Al Co., Ltd. | | 510(k) Number: | K212624 | {4}------------------------------------------------ #### 4 INTENDED USE / INDICATIONS FOR USE: qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans. qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm. The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities. The system is suitable for adults ≥ 22 years of age. The device is used to aid the intended users and results are not intended to be used on a stand-alone basis for clinical decision making or otherwise preclude clinical assessment of CTR cases. #### ഗ DEVICE DESCRIPTION The qXR-CTR is a non-invasive software medical device designed to be installed on the computer with specific system requirements. It is a radiological computer-assisted software system that automatically analyzes DICOM chest X-ray images in PA view and outputs the cardiac diameter, thoracic diameter, and CTR through an artificial intelligence algorithm. The structured report includes a preview of the compressed chest X-ray image with the automatically derived CTR result and annotation line, indicating the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity. #### ട COMPARISON OF THE PREDICATE DEVICE qXR-CTR is technologically similar to the predicate device, EFIA iCTR Assessment in regard to intended use and technological characteristics. Both are medical image management and processing system intended to read chest X-rays to measure target structures (cardiac and thoracic diameter). The algorithms function similarly and there are no notable technological differences between the subject and predicate devices. In terms of establishing substantial equivalence, the subject and predicate device have the same intended use, as an image processing tool that measures anatomical structures and produces caselevel output. The indications for use proposed for the subject device are similar those of the predicate device. | | Predicate Device | Subject Device | |------------------------|----------------------------------------------------------------------|--------------------------------------------| | Device Name | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | qXR-CTR | | 510(k) Number | K212624 | NA | | Regulation | 21 CFR 892.2050 | 21 CFR 892.2050 | | Regulation Description | radiological computer- assisted software | radiological computer-assisted software | | Table 1 Comparison between gXR-CTR and the Predicate Device | | | |-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Predicate Device | Subject Device | | Product Code | QIH | QIH | | Device type | Quantifying software | Quantifying software | | Manufacturer | Ever Fortune.Al Co., Ltd. | Qure.ai Technologies | | Intended use / Indications for Use | EFAI Intelligent Cardiothoracic Ratio Assessment System (or iCTR) is a software for use by hospitals and clinics to automatically assess the cardiothoracic ratio (CTR) of a chest X-ray image from the X- ray imager subject. The iCTR is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR of a chest X-ray image in posterior-anterior (PA) chest view using an artificial intelligence algorithm. Intended users of the software are aimed to the physicians or other licensed practitioners in the healthcare institutions, such as clinics, hospitals, healthcare facilities, residential care facilities and long-term care services. The system is suitable for adults between 20 - 80 years of age. Its results are not intended to be used on a stand-alone basis for clinical decision making or otherwise preclude clinical assessment of cardiothoracic ratio (CTR) cases. | qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans. qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior- anterior view chest view using an artificial intelligence algorithm. The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities. The system is suitable for adults ≥ 22 years of age. The device is used to aid the intended users and results are not intended to be used on a stand-alone basis for clinical decision making or otherwise preclude clinical assessment of CTR cases. | | Algorithm for measurement of target structures | AI Algorithm | AI Algorithm | | Modality | Chest X-ray in Digital Radiography (DR) | Chest X-ray in Digital Radiography (DR) | | Input | Post-anterior (PA) view chest X-ray image | Post-anterior (PA) view chest X-ray image | | Input format | DICOM | DICOM | | Output Format | Reports, DICOM Secondary Capture series | Pdf report is generated, DICOM Secondary capture is returned to the PACS | | Report Structure | Report will be output in the DICOM and JSON file format | Report will be output in the DICOM and JSON file format which is structured with following information | | | Predicate Device | Subject Device | | | | | | | following information and function tool: 1) CTR 2) adjustable annotation line (maximal inner border diameter of thoracic cavity and maximal diameter of heart) 3) the trajectory of CTR (including chest X-ray) | and function tool: 1) CTR 2) annotation line (maximal inner border diameter of thoracic cavity and maximal diameter of heart) | | Intended User | Physicians or other licensed practitioners in the healthcare institutions | Physicians or other licensed practitioners in the healthcare institutions | | Target Population | 20-80 years | ≥ 22 years | | Modality | Chest X-ray in Digital Radiography | Chest X-ray in Digital Radiography | | Intended Use Environment | Healthcare institutions (Clinics, hospitals, healthcare facilities, residential care facilities and long-term care services) | Healthcare institutions (Clinics, hospitals, healthcare facilities, residential care facilities and long-term care services) | | Software device that | Yes | Yes | | operates on off the shelf | | | | hardware | | | | Software devices uses | Yes | Yes | | software algorithms for image | | | | Diameter Measurement | Yes | Yes | | Storage | Saved in JSON and DICOM file format text for DICOM and DICOM file format | The text report is generated with the CXR scan on a Structured Report (SR) format for PACS-based mode. For the Web-based mode, the user can download a PDF version of the report with the same information | | Software Requirement | Ubuntu 18.04 (Web browser: chrome 88.0.4324.182 or above) | Ubuntu 20.04+ | | Performance metrics of the predicate device and qXR-CTR | | | | Performance level | RMSE: | RMSE: | | | Cardiac Diameter = 8.81 mm Thoracic Diameter = 14.4 mm | Cardiac Diameter = 7.55 mm Thoracic Diameter = 5.43 mm | | | Mean Absolute Error: NR | Mean Absolute Error: 5.66 (5.0) mm | | Measurement | Root Mean Squared Error (95% CI) in mm | Mean Absolute Error (SD) in mm…