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. · LLZ System, Image Processing, Radiological
Cleared on Oct 31, 2018 as substantially equivalent to K151919 (Vital Images, Inc., 2015) after a 555-day review. Its family tree reaches back 8 generations to 1995. 6 later devices descend from it.
- Decided
- Oct 31, 2018
- Review
- 555 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K954355 (1995). 12 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 7 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
- 6 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
- 5 generations backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- 4 generations backK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
- 3 generations backK071513 Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
- 2 generations backK083227 Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc. · 2008
- 1 generation backK151919 Vitrea CT Lung Density Analysis SoftwareVital Images, Inc. · 2015
- This deviceK171199 AVIEWCoreline Soft Co., Ltd. · 2018
- Descendant · cites it directly · 5 of its ownK200714 AVIEWCoreline Soft Co., Ltd. · 2020
- Descendant · 2 generations on · 4 of its ownK214036 AVIEWCoreline Soft Co., Ltd. · 2022
- Descendant · 3 generations on · 2 of its ownK233211 Aview CacCoreline Soft Co., Ltd. · 2024
- Descendant · 4 generations on · 0 of its ownK250288 TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK243689 AVIEWCoreline Soft Co., Ltd. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K200714AVIEWCoreline Soft Co., Ltd. · 2020 · cites it directly5descendants
- K214036AVIEWCoreline Soft Co., Ltd. · 2022 · 2 generations on4descendants
- K233211Aview CacCoreline Soft Co., Ltd. · 2024 · 3 generations on2descendants
- K250288TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc. · 2025 · 4 generations on0descendants
- K243689AVIEWCoreline Soft Co., Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −7 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| −6 | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
| −5 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −4 | K043469 | Syngo Inspace 4D | Siemens AG Medical Solutions | 2005 | — |
| −3 | K071513 | Inspace 4D Software Package with Extended Functionality | Siemens Medical Solutions | 2007 | — |
| −2 | K083227 | Vida Pulmonary Workstation 2 (PW2) | Vida Diagnostics, Inc. | 2008 | — |
| −1 | K151919 | Vitrea CT Lung Density Analysis Software | Vital Images, Inc. | 2015 | — |
| 0 (this device) | K171199 | AVIEW | Coreline Soft Co., Ltd. | 2018 | — |
| +1 | K200714 | AVIEW | Coreline Soft Co., Ltd. | 2020 | — |
| +2 | K214036 | AVIEW | Coreline Soft Co., Ltd. | 2022 | — |
| +3 | K233211 | Aview Cac | Coreline Soft Co., Ltd. | 2024 | — |
| +4 | K250288 | TeraRecon Cardiovascular.Calcification.CT | Terarecon,Inc. | 2025 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K151919 | Vitrea CT Lung Density Analysis SoftwareSummary page 5…W 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. Substan… | 2015 |
| † | K150258 | Vitrea, Version 7.0 Medical Image Processing Software | 2015 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200714 | AVIEW | 2020 | 5 |
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 23 years and passes through 9 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K200714 (Coreline Soft Co., Ltd., 2020) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K151919.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
AVIEW 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171199: AVIEW.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171199
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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