510(k) Report

510(k) · Cleared

Cleared

AVIEW

K243689510(k) SpecialCleared Mar 19, 2025110-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

  1. Root · 11 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
  2. 7 generations between
  3. 3 generations backK171199 AVIEWCoreline Soft Co., Ltd. · 2018
  4. 2 generations backK200714 AVIEWCoreline Soft Co., Ltd. · 2020
  5. 1 generation backK214036 AVIEWCoreline Soft Co., Ltd. · 2022
  6. This deviceK243689 AVIEWCoreline Soft Co., Ltd. · 2025
Show all 11 generations
  1. Root · 11 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
  2. 10 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
  3. 9 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
  4. 8 generations backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
  5. 7 generations backK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
  6. 6 generations backK071513 Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
  7. 5 generations backK083227 Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc. · 2008
  8. 4 generations backK151919 Vitrea CT Lung Density Analysis SoftwareVital Images, Inc. · 2015
  9. 3 generations backK171199 AVIEWCoreline Soft Co., Ltd. · 2018
  10. 2 generations backK200714 AVIEWCoreline Soft Co., Ltd. · 2020
  11. 1 generation backK214036 AVIEWCoreline Soft Co., Ltd. · 2022
  12. This deviceK243689 AVIEWCoreline Soft Co., Ltd. · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K954355Advantage Windows 3D with Navigator OptionGeneral Electric Co.1995—
−10K974715Advantage 3D XRGE Medical Systems1998—
−9K9846343D-AngioSiemens Medical Corp.1999—
−8K011447IN Space 3DSiemens Medical Solutions USA, Inc.2001—
−7K043469Syngo Inspace 4DSiemens AG Medical Solutions2005—
−6K071513Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions2007—
−5K083227Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc.2008—
−4K151919Vitrea CT Lung Density Analysis SoftwareVital Images, Inc.2015—
−3K171199AVIEWCoreline Soft Co., Ltd.2018—
−2K200714AVIEWCoreline Soft Co., Ltd.2020—
−1K214036AVIEWCoreline Soft Co., Ltd.2022—
0 (this device)K243689AVIEWCoreline Soft Co., Ltd.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199820
200010
FIG. 1 — Lineage of K243689, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K214036AVIEW
Summary page 5
…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K214036 AVIEW…
Coreline Soft Co., Ltd.2022—

Also cleared against K214036: 1 other device →

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 devices

QIH 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

2019: 22020: 112021: 192022: 252023: 452024: 642025: 942026 (partial year): 78
2007high 94 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QIH

150in 2025

2020: 145 days median2021: 125 days median2022: 134 days median2023: 151 days median2024: 141 days median2025: 150 days median2026 (partial year): 130 days median
2007high 151 (2023) · low 125 (2021)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QIH

1so far in 2026, the most since 2007

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · QIH

4in 2025

2024: 22025: 4
2007high 4 (2025) · low 0 (2007)2025

MAUDE reports naming product code QIH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20192—00
20201114500
20211912500
20222513400
20234515100
20246414102
20259415004
2026781301—

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.

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