510(k) · Cleared
ClearedAVIEW
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coreline Soft Co., Ltd. · QIH Automated Radiological Image Processing Software
Cleared on Mar 19, 2025 as substantially equivalent to K214036 (Coreline Soft Co., Ltd., 2022) after a 110-day review. Its family tree reaches back 11 generations to 1995.
- Decided
- Mar 19, 2025
- Review
- 110 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K954355 (1995). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 7 generations between
- 3 generations backK171199 AVIEWCoreline Soft Co., Ltd. · 2018
- 2 generations backK200714 AVIEWCoreline Soft Co., Ltd. · 2020
- 1 generation backK214036 AVIEWCoreline Soft Co., Ltd. · 2022
- This deviceK243689 AVIEWCoreline Soft Co., Ltd. · 2025
Show all 11 generations
- Root · 11 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 10 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
- 9 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
- 8 generations backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- 7 generations backK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
- 6 generations backK071513 Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
- 5 generations backK083227 Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc. · 2008
- 4 generations backK151919 Vitrea CT Lung Density Analysis SoftwareVital Images, Inc. · 2015
- 3 generations backK171199 AVIEWCoreline Soft Co., Ltd. · 2018
- 2 generations backK200714 AVIEWCoreline Soft Co., Ltd. · 2020
- 1 generation backK214036 AVIEWCoreline Soft Co., Ltd. · 2022
- This deviceK243689 AVIEWCoreline Soft Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −10 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| −9 | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
| −8 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −7 | K043469 | Syngo Inspace 4D | Siemens AG Medical Solutions | 2005 | — |
| −6 | K071513 | Inspace 4D Software Package with Extended Functionality | Siemens Medical Solutions | 2007 | — |
| −5 | K083227 | Vida Pulmonary Workstation 2 (PW2) | Vida Diagnostics, Inc. | 2008 | — |
| −4 | K151919 | Vitrea CT Lung Density Analysis Software | Vital Images, Inc. | 2015 | — |
| −3 | K171199 | AVIEW | Coreline Soft Co., Ltd. | 2018 | — |
| −2 | K200714 | AVIEW | Coreline Soft Co., Ltd. | 2020 | — |
| −1 | K214036 | AVIEW | Coreline Soft Co., Ltd. | 2022 | — |
| 0 (this device) | K243689 | AVIEW | Coreline Soft Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K214036 | AVIEWSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K214036 AVIEW… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 9 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 1 other device also cites its predicate K214036.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
AVIEW provides CT values for pulmonary tissue from CT thoracic and cardiac datasets. This software can be used to support the physician providing quantitative analysis of CT images by image segmentation of sub-structures in the lung, lobe, airways, fissures completeness, cardiac, density evaluation, and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data set on-premises and as a cloud environment to allow users to connect…
Read the full statement (313 words)
AVIEW provides CT values for pulmonary tissue from CT thoracic and cardiac datasets. This software can be used to support the physician providing quantitative analysis of CT images by image segmentation of sub-structures in the lung, lobe, airways, fissures completeness, cardiac, density evaluation, and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data set on-premises and as a cloud environment to allow users to connect by various environments such as mobile devices and Chrome browsers. Converts the sharp kernel to soft kernel for quantitative analysis of segmenting low attenuation areas of the lung Characterizing nodules in the lung in a single study or over the time course of several thoracic studies. Characterizations include nodule type, location of the nodule, and measurements such as size (major axis, minor axis), estimated effective diameter from the volume of the nodule, the volume of the nodule, Mean HU(the average value of the CT pixel inside the nodule in HU), Minimum HU, Max HU, mass(mass calculated from the CT pixel value), and volumetric measures(Solid major; length of the longest diameter measure in 3D for a solid portion of the nodule, Solid 2nd Major: The size of the longest diameter of the solid part, measured in sections perpendicular to the Major axis of the solid portion of the nodule), VDT (Volume doubling time), and Lung-RADS (classification proposed to aid with findings.)). The system automatically performs the measurement, allowing lung nodules and measurements to be displayed and, integrate with FDA certified AVIEW Lung Nodule CAD (Computer aided detection) (K221592). It also provides the Agatston score, volume score, and mass score by the whole and each artery by segmenting four main arteries (right coronary artery, left main coronary, left anterior descending, and left circumflex artery). Based on the calcium score provides CAC risk based on age and gender The device is indicated for adult patients only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243689 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243689: AVIEW.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243689
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026