Who is the manufacturer of AVIEW?

Coreline Soft Co., Ltd. filed the 510(k) submission for AVIEW (K171199).

What is the FDA product code for AVIEW?

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

What is the regulatory pathway for AVIEW?

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

What are the predicate devices for AVIEW?

Vitrea CT Lung Density Analysis Software (K151919); Vitrea, Version 7.0 Medical image Processing Software (K150258).

Who can help prepare an FDA 510(k) submission like AVIEW?

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.

AVIEW

K171199 · Coreline Soft Co., Ltd. · LLZ · Oct 31, 2018 · Radiology

Device Facts

Record ID	K171199
Device Name	AVIEW
Applicant	Coreline Soft Co., Ltd.
Product Code	LLZ · Radiology
Decision Date	Oct 31, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

A VIEW provides CT values for pulmonary tissue from CT thoracic datasets. This software can be used to support the physician quantitatively in the diagnosis, followup evaluation and documentation of CT lung tissue images by providing image segmentation of sub-structures in the left and right lung (e.g., the five lobes and airway), volumetric and structural analysis, density evaluations and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data sets. AVIEW is not meant for primary image Interpretation in mammography.

Device Story

AVIEW is a PC-based software application for processing and analyzing thoracic CT datasets. It ingests DICOM 3.0 images from storage devices or imaging systems. The software performs semi-automatic segmentation of pulmonary sub-structures, including the five lung lobes and the airway. It calculates volumetric data, structural metrics, and density evaluations (e.g., Lower Attenuation Area index, D-slope, airway lumen/wall area). The device provides visualization tools, including multi-planar reconstruction (MPR) and 3D rendering with color-coded Hounsfield Unit (HU) overlays. It generates graphical reports and exports quantification results to CSV. Used in clinical settings by radiologists and physicians, the output serves as an adjunctive tool to support clinical decision-making, diagnosis, and follow-up evaluation of lung tissue. It does not perform primary image interpretation for mammography.

Clinical Evidence

Bench testing only. Verification and validation activities included unit testing, system testing, DICOM compatibility, LAA analysis, LAA size analysis, airway wall measurement, and reliability testing. The device met all pre-determined pass/fail criteria.

Technological Characteristics

Software-only device; runs on IBM-compatible PC/network (Windows 7, 8, 10). Inputs: DICOM 3.0 thoracic CT datasets. Features: semi-automatic segmentation, volumetric/density quantification, MPR/3D visualization. Connectivity: DICOM network communication and file import/export. No patient contact; non-life-sustaining.

Indications for Use

Indicated for use by physicians to support quantitative diagnosis and follow-up evaluation of CT thoracic lung tissue images, including segmentation of lung sub-structures (lobes, airway), volumetric/structural analysis, and density evaluation.

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

Vitrea CT Lung Density Analysis Software (K151919)
Vitrea, Version 7.0 Medical image Processing Software (K150258)

Related Devices

K173821 — LungQ Software · Thirona Corporation · Jun 5, 2018
K200990 — VIDAvision · Vida Diagnostics, Inc. · Aug 7, 2020
K212494 — Lung Image Analysis · Pulmonx Corporation · Sep 2, 2021
K151919 — Vitrea CT Lung Density Analysis Software · Vital Images, Inc. · Oct 10, 2015
K214036 — AVIEW · Coreline Soft Co., Ltd. · Dec 23, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. October 31, 2018 Coreline Soft Co., Ltd. % Priscilla Chung Regulatory Affairs Consulting LK Consulting Group USA, Inc 690 Roosevelt IRVINE, CA 92620 Re: K171199 Trade/Device Name: AVIEW Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: October 9, 2018 Received: October 12, 2018 Dear Priscilla Chung: 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 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 {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Digitally signed Michael by Michael D. D. O'hara - o'hara -s Date: 2018.10.31 For S 16:54:04 -04'00' Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K171199 Device Name AVIEW #### Indications for Use (Describe) A VIEW provides CT values for pulmonary tissue from CT thoracic datasets. This software can be used to support the physician quantitatively in the diagnosis, followup evaluation of CT lung tissue images by providing image segmentation of sub-structures in the left and right lung (e.g., the five lobes and airway), volumetric and structural analysis, density evaluations and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data sets. A VIEW is not meant for primary image Interpretation in mammography. 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. 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 (K171199) ### 1. Date: 10/09/2018 ## 2. Applicant / Submitter Coreline Soft Co., Ltd. 4, 5F (Yeonnam-dong), 49, World Cup buk-ro 6-gil, Mapo-gu, Seoul, 03991, Republic of Korea ### 3. U.S. Designated Agent Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine CA 92620 Tel: 714.202.5789 Fax: 714.409.3357 Email: juhee.c@LKconsultingGroup.com #### 4. Trade/Proprietary Name: AVIEW # 5. Common Name: Image Processing Software #### 6. Classification: System, image processing, radiological (21CFR 892.2050, Product code LLZ, Class 2, Radiology) #### 7. Device Description: The AVIEW is a software product which can be installed on a PC. It shows images taken with the interface from various storage devices using DICOM 3.0 which is the digital image and communication standard in medicine. It also offers functions such as reading, manipulation, analyzing, post-processing, saving and sending images by using the software tools. {4}------------------------------------------------ # 8. Indication for Use: A VIEW provides CT values for pulmonary tissue from CT thoracic datasets. This software can be used to support the physician quantitatively in the diagnosis, followup evaluation and documentation of CT lung tissue images by providing image segmentation of sub-structures in the left and right lung (e.g., the five lobes and airway), volumetric and structural analysis, density evaluations and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data sets. AVIEW is not meant for primary image Interpretation in mammography. # 9. Predicate Device: - Primary Predicate Device: Vitrea CT Lung Density Analysis Software (K151919) - Reference Predciate Device: Vitrea, Version 7.0 Medical image Processing Software (K150258) # 10. Substantial Equivalence: A VIEW has the same intended use and the principle of operation, and also has similar features to the predicate devices. Vitrea (K150258 and K151919). There might be slight differences in features and menu, but these differences between the predicate device and the proposed device are not so significant since they do not raise any new or potential safety risks to the user or patient and questions of safety or effectiveness. Based on the results of software validation and verification tests, we conclude that the proposed device is substantially equivalent to the predicate devices. | | Subject Device | Primary Predicate Device | Reference Device | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | AVIEW | Vitrea CT Lung Density Analysis Software | Vitrea, Version 7.0 Medical image Processing Software | | Classification Name | System, Image Processing, Radiological | System, X-ray, Tomography, Computed | System, Image Processing, Radiological | | Regulatory Number | 21 CFR 892.2050 | 21 CFR 892.1750 | 21 CFR 892.2050 | | Product Code | LLZ | JAK | LLZ | | Classification | Class II | Class II | Class II | | Review Panel | Radiology | Radiology | Radiology | | 510K number | K171199 | K151919 | K150258 | | Indications for Use | AVIEW provides CT values for pulmonary tissue from CT thoracic datasets. This software | The Vitrea Lung Density Analysis software provides CT values for the pulmonary tissue from | Vitrea is a medical diagnostic system that allows the processing, review, analysis, | | | can be used to support the physician quantitatively in the diagnosis, followup evaluation and documentation of CT lung tissue images by providing image segmentation of sub- structures in the left and right lung (e.g., the five lobes and airway), volumetric and structural analysis, density evaluations and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data sets. AVIEW is not meant for primary image Interpretation in mammography. | CT thoracic datasets. Three-dimensional(3D) segmentation of the left lung and right lung, volumetric analysis, density evaluation and reporting tools are integrated in a specific workflow to offer the physician a quantitative support for diagnosis and follow-up evaluation of lung tissue images. | communication and media interchange of multi- dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image. Interpretation in mammography. | | Platform | IBM-compatible PC or PC network | IBM-compatible PC or PC network | IBM-compatible PC or PC network | | Operation System | Microsoft Window 7, 8, 10 | Microsoft Window XP, Window VISTA, Window 7, 8 | Microsoft Window XP, Window VISTA, Window 7, 8 | | User Interface | Monitor, Mouse, Keyboard | Monitor, Mouse, Keyboard | Monitor, Mouse, Keyboard | | Image Input Sources | Images can be scanned, loaded from card readers, or imported from a radiographic imaging device | Images can be scanned, loaded from digital cameras or card readers, or imported from a radiographic imaging device | Images can be scanned, loaded from digital cameras or card readers, or imported from a radiographic imaging device | | 32 bit / 64 bit | 64 bit | 32 / 64 bit | 32 / 64 bit | | Image format | DICOM | DICOM | DICOM | | Image Measurement Tools | Ruler (line and 3D), Tapeline (curve, poly and 3D), Angle (3-point, 4 point, and 3D), pixel values, area of ROI (rectangle, circle, ellipse), volume | Ruler (linear), Tapeline(curve), Angle (3- point, 4 point, and 3D), pixel values, area of a region of interest, | Ruler (linear), Tapeline(curve), Angle (3- point, 4 point, and 3D), pixel values, area of a region of interest, | | Image viewing | Axial, sagittal, and coronal image, oblique slice, cube view | Axial, sagittal and coronal images, oblique slice, cube view | Axial, sagittal and coronal images, oblique slice, cube view | | Image manipulation | Panning, rotating, zooming, windowing, inverting, Coloring, Oblique, Note (text overlay) | Panning, rotating, zooming, windowing, inverting, text overlay, volume of interest overlay | Panning, rotating, zooming, windowing, inverting, text overlay, volume of interest overlay | | | (volume of interest overlay) | | | | General Description | AVIEW is an image processing software as a medical device. It assists in analyzing pulmonary CT datasets and displaying the analysis results. | Vitrea CT Lung Density Analysis assists in analyzing lung densities and volumes. It semi- automatically segments lung tissues with quantifiable controls and renderings to aid communication with the pulmonologist. | Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. | | DICOM | This receives DICOM data from CT by DICOM communication Conducts DICOM data communication with PACS. It also imports DICOM file directly, saves by using export function. | Retrieve image data over the network via DICOM | Retrieve image data over the network via DICOM | | Lung Analysis Functions | Semi-automatic segmentation of lungs, lobes and airways Visualization of multi- planar reconstructed (MPR) images and 3D rendered images, with color-defined Hounsfield Unit (HU) ranges Calculation of LAA (Lower Attenuation Area) index with HU density histogram, volume measurements and percentile index Calculation of LAA cluster size distribution with D-slope Graphical visualization of the above quantification results for reporting Export of quantification results to CSV tables Visualization of LAA% for each of 5 lobes Measurements of the airway branches, such as, lumen area and wall area | Semi-automatic right lung, left lung, and airway segmentation Visualization of lung density with color-defined Hounsfield Unit (HU) range Lung density result quantification with HU density range, volume measurements, lung density index, and the PD15% measurement Density graph/histogram of the classified lung voxels' relative frequencies Overlay of density quantification results and density graph histogram for reporting Export of density values and curves to CSV tables or copy to clipboard for insertion into a report Comparison of upper and lower lung density index ratios | N/A | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ # 11. Technological Characteristics: A VIEW is a software device that does not contact the patient, nor does it control any life sustaining devices. Results produced by the software tools are dependent on the interpretation of trained and licensed radiologists, clinicians and referring physicians as an adjunctive to standard radiology practices for diagnosis. ## 12. Performance Data: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria. A summary of the conducted tests is as below: - । Unit test - System test - - DICOM test - - -LAA analysis test - LAA size analysis test - - Airway wall measurement test - - -Reliability test - CT image compatibility test - #### 13. Conclusion: The new device and predicate device are substantially equivalent in the areas of technical characteristics, general functions, application, and intended use. The new device does not introduce a fundamentally new scientific technology, and the nonclinical tests demonstrate that the device is safe and effective. Therefore, it is our opinion that the AVIEW described in this submission is substantially equivalent to the predicate device.