510(k) · Cleared
ClearedTeraRecon Cardiovascular.Calcification.CT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terarecon,Inc. · QIH Automated Radiological Image Processing Software
Cleared on Oct 23, 2025 as substantially equivalent to K233211 (Coreline Soft Co., Ltd., 2024) after a 265-day review. Its family tree reaches back 12 generations to 1995.
- Decided
- Oct 23, 2025
- Review
- 265 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K954355 (1995). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 8 generations between
- 3 generations backK200714 AVIEWCoreline Soft Co., Ltd. · 2020
- 2 generations backK214036 AVIEWCoreline Soft Co., Ltd. · 2022
- 1 generation backK233211 Aview CacCoreline Soft Co., Ltd. · 2024
- This deviceK250288 TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc. · 2025
Show all 12 generations
- Root · 12 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 11 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
- 10 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
- 9 generations backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- 8 generations backK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
- 7 generations backK071513 Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
- 6 generations backK083227 Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc. · 2008
- 5 generations backK151919 Vitrea CT Lung Density Analysis SoftwareVital Images, Inc. · 2015
- 4 generations backK171199 AVIEWCoreline Soft Co., Ltd. · 2018
- 3 generations backK200714 AVIEWCoreline Soft Co., Ltd. · 2020
- 2 generations backK214036 AVIEWCoreline Soft Co., Ltd. · 2022
- 1 generation backK233211 Aview CacCoreline Soft Co., Ltd. · 2024
- This deviceK250288 TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −11 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| −10 | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
| −9 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −8 | K043469 | Syngo Inspace 4D | Siemens AG Medical Solutions | 2005 | — |
| −7 | K071513 | Inspace 4D Software Package with Extended Functionality | Siemens Medical Solutions | 2007 | — |
| −6 | K083227 | Vida Pulmonary Workstation 2 (PW2) | Vida Diagnostics, Inc. | 2008 | — |
| −5 | K151919 | Vitrea CT Lung Density Analysis Software | Vital Images, Inc. | 2015 | — |
| −4 | K171199 | AVIEW | Coreline Soft Co., Ltd. | 2018 | — |
| −3 | K200714 | AVIEW | Coreline Soft Co., Ltd. | 2020 | — |
| −2 | K214036 | AVIEW | Coreline Soft Co., Ltd. | 2022 | — |
| −1 | K233211 | Aview Cac | Coreline Soft Co., Ltd. | 2024 | — |
| 0 (this device) | K250288 | TeraRecon Cardiovascular.Calcification.CT | Terarecon,Inc. | 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 |
|---|---|---|---|
| * | K233211 | Aview CacSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K2332111 AVIEW CAC… | 2024 |
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 10 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 1 other device also cites its predicate K233211.
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?
TeraRecon Cardiovascular.Calcification.CT is intended to provide an automatic 3D segmentation of calcified plaques within the coronary arteries and outputs a mask for calcium scoring systems to use for calculations. The results of TeraRecon Cardiovascular.Calcification.CT are intended to be used in conjunction with other patient information by trained professionals who are responsible for making any patient management decision per the standard of care.…
Read the full statement (207 words)
TeraRecon Cardiovascular.Calcification.CT is intended to provide an automatic 3D segmentation of calcified plaques within the coronary arteries and outputs a mask for calcium scoring systems to use for calculations. The results of TeraRecon Cardiovascular.Calcification.CT are intended to be used in conjunction with other patient information by trained professionals who are responsible for making any patient management decision per the standard of care. TeraRecon Cardiovascular.Calcification.CT is a software as a medical device (SaMD) deployed as a containerized application. The device inputs are CT heart without contrast DICOM images. The device outputs are DICOM result files which may be viewed utilizing DICOM-compliant systems. The device does not alter the original input data and does not provide a diagnosis.
TeraRecon Cardiovascular.Calcification.CT is indicated to generate results from Calcium Score CT scans taken of adult patients, 30 years and older, except patients with pre-existing cardiac devices, electrodes, previous and established ischemic diseases (IMA, bypass grafts, stents, PTCA) and Thoracic metallic devices. The device is not specific to any gender, ethnic group, or clinical condition. The device's use should be limited to CT scans acquired on General Electric (GE) or Siemens Healthcare or their subsidiaries (e.g. GE Healthcare) equipment. Use of the device with CT scans from other manufacturers is not recommended.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250288: TeraRecon Cardiovascular.Calcification.CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250288
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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