510(k) · Cleared
ClearedCalcium Scoring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on May 12, 1999 as substantially equivalent to K972903 (Imatron, Inc., 1997) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1995. 166 later devices descend from it.
- Decided
- May 12, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945428 (1995). 3 ancestors in all. 166 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK945428 Scribe (TM) Diagnostic Imaging WorkstationMulti-Dimensional Imaging, Inc. · 1995
- 1 generation backK960911 Netra Workstation System & Netra MD SoftwareScimage, Inc. · 1996
- This deviceK990426 Calcium ScoringSiemens Medical Solutions USA, Inc. · 1999
- Descendant · cites it directly · 112 of its ownK043111 Plaqueview Software, Model CSPV-0001AToshiba America Medical Systems, In.C · 2004
- Descendant · 2 generations on · 111 of its ownK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 82 of its ownK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- Descendant · cites it directly · 45 of its ownK072737 CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C · 2007
- Descendant · 2 generations on · 29 of its ownK083446 Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009
Showing 5 of 166 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 166 · See all- K043111Plaqueview Software, Model CSPV-0001AToshiba America Medical Systems, In.C · 2004 · cites it directly112descendants
- K061624Vitrea, Version 3.9Vital Images, Inc. · 2006 · 2 generations on111descendants
- K071331Vitrea Version 4.0Vital Images, Inc. · 2007 · 2 generations on82descendants
- K072737CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C · 2007 · cites it directly45descendants
- K083446Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009 · 2 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945428 | Scribe (TM) Diagnostic Imaging Workstation | Multi-Dimensional Imaging, Inc. | 1995 | — |
| −1 | K960911 | Netra Workstation System & Netra MD Software | Scimage, Inc. | 1996 | — |
| 0 (this device) | K990426 | Calcium Scoring | Siemens Medical Solutions USA, Inc. | 1999 | — |
| +1 | K043111 | Plaqueview Software, Model CSPV-0001A | Toshiba America Medical Systems, In.C | 2004 | — |
| +2 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| +2 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| +1 | K072737 | CSCS-001A Calcium Scoring Package | Toshiba America Medical Systems, In.C | 2007 | — |
| +2 | K083446 | Cardiac Function Analysis, Calcium Scoring | Ziosoft, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 5 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 8 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 11 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 7 | 0 |
| 2022 | 13 | 0 |
| 2023 | 13 | 0 |
| 2024 | 19 | 0 |
| 2025 | 21 | 0 |
| 2026 | 13 | 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K972903 | Imatron Ultra Access Workstation with Cardiac Software ExtensionsSummary page 2…to a paper report or to film. « Substantial Equivalence: Siemens Calcium Scoring is substantially equivalent to the following devices: 1. - Imatron Ultra Access Device (K972903) cleared by FDA on 11/04/97 2. - SClmage NetraMD Device (K960911) cleared by FDA on 05/29/96 ager, Regulatory Submissfons Imagin… | 1997 |
| * | K960911 | Netra Workstation System & Netra MD SoftwareSummary page 2…Calcium Scoring is substantially equivalent to the following devices: 1. - Imatron Ultra Access Device (K972903) cleared by FDA on 11/04/97 2. - SClmage NetraMD Device (K960911) cleared by FDA on 05/29/96 ager, Regulatory Submissfons Imaging Systems Group, Siemens Medical Systems _/C DEPA… | 1996 |
What descends from it? (166)
See all 1665 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K043111 (Toshiba America Medical Systems, In.C, 2004) has gone furthest, with 112 descendants of its own.
- 4 other devices also cite its predicate K972903.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
From user specified sets of CT cardiac images, Calcium Scoring can be used to: - Allow the user to interactively indicate regions of detected calcification To allow the user to allocate each detected region to one of several coronary arteries To estimate algorithmically a score for the amount of detected calcification in each allocated artery To prepare reports including caicium score data, imagery, ECG traces, Comparison of score to cited literature and…
Read the full statement (138 words)
From user specified sets of CT cardiac images, Calcium Scoring can be used to: -
Allow the user to interactively indicate regions of detected calcification
To allow the user to allocate each detected region to one of several coronary arteries
To estimate algorithmically a score for the amount of detected calcification in each allocated artery
To prepare reports including caicium score data, imagery, ECG traces, Comparison of score to cited literature and additional relevant information
The calcium-scoring package is a diagnostic tool that can be used to evaluate the caicified plaques in the caronary arteries, which is a risk factor for coronary artery disease. Calcium scoring may be used to monitor the progression or regression overtime of the amount or volume of calcium in the coranary arteries, which may be related to the pregnosis of a cardiac attack.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990426: Calcium Scoring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990426
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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