510(k) · Cleared
ClearedImatron Ultra Access Workstation with Cardiac Software Extensions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imatron, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Nov 4, 1997 after a 90-day review. The FDA summary names its predicate without a number. 1 of the 354 devices in its family, counting itself, has a Class I recall. 353 later devices descend from it.
- Decided
- Nov 4, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 0
353 later devices descend from it, 5 citing it directly. 1 of the 354 devices in this family, counting this one, has a Class I recall.
- This deviceK972903 Imatron Ultra Access Workstation with Cardiac Software ExtensionsImatron, Inc. · 1997
- Descendant · cites it directly · 207 of its ownK012086 Aquariusnet ServerTerarecon,Inc. · 2001
- Descendant · cites it directly · 166 of its ownK990426 Calcium ScoringSiemens Medical Solutions USA, Inc. · 1999
- Descendant · 2 generations on · 134 of its ownK061214 Aquariusaps ServerTerarecon,Inc. · 2006
- Descendant · 2 generations on · 112 of its ownK043111 Plaqueview Software, Model CSPV-0001AToshiba America Medical Systems, In.C · 2004
- Descendant · 3 generations on · 111 of its ownK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
Showing 5 of 353 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…7 generations on · 2025
Most influential descendants
Showing 5 of 353 · See all- K012086Aquariusnet ServerTerarecon,Inc. · 2001 · cites it directly207descendants
- K990426Calcium ScoringSiemens Medical Solutions USA, Inc. · 1999 · cites it directly166descendants
- K061214Aquariusaps ServerTerarecon,Inc. · 2006 · 2 generations on134descendants
- K043111Plaqueview Software, Model CSPV-0001AToshiba America Medical Systems, In.C · 2004 · 2 generations on112descendants
- K061624Vitrea, Version 3.9Vital Images, Inc. · 2006 · 3 generations on111descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972903 | Imatron Ultra Access Workstation with Cardiac Software Extensions | Imatron, Inc. | 1997 | — |
| +1 | K012086 | Aquariusnet Server | Terarecon,Inc. | 2001 | — |
| +1 | K990426 | Calcium Scoring | Siemens Medical Solutions USA, Inc. | 1999 | — |
| +2 | K061214 | Aquariusaps Server | Terarecon,Inc. | 2006 | — |
| +2 | K043111 | Plaqueview Software, Model CSPV-0001A | Toshiba America Medical Systems, In.C | 2004 | — |
| +3 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 8 | 0 |
| 2007 | 8 | 0 |
| 2008 | 11 | 0 |
| 2009 | 7 | 0 |
| 2010 | 9 | 0 |
| 2011 | 8 | 0 |
| 2012 | 16 | 0 |
| 2013 | 9 | 0 |
| 2014 | 7 | 0 |
| 2015 | 13 | 0 |
| 2016 | 7 | 0 |
| 2017 | 12 | 0 |
| 2018 | 22 | 0 |
| 2019 | 14 | 0 |
| 2020 | 26 | 0 |
| 2021 | 14 | 0 |
| 2022 | 26 | 0 |
| 2023 | 26 | 0 |
| 2024 | 36 | 0 |
| 2025 | 38 | 1 |
| 2026 | 27 | 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.
1 device in this family has a Class I recall. 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? (4)
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 |
|---|---|---|---|
| * | — | C150XP’s Physician Workstation Named without a submission number | |
| * | — | NetraMD Workstation Named without a submission number | |
| * | — | AIDP (Acculmage, Inc. Image Display Processor) Imatron/DICOM Image Processing Workstation Named without a submission number | |
| * | — | VRSAPP Workstation Named without a submission number |
What descends from it? (353)
See all 3535 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K012086 (Terarecon,Inc., 2001) has gone furthest, with 207 descendants of its own.
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?
The Imatron Ultra Access Workstation is intended as an accessory to Imatron’s Ultrafast Computed Tomography (CT) Scanner, a cleared device. The Ultra Access Workstation accepts data from Imatron’s Ultrafast CT scanner and allows for advanced post processing of such data.
Thus, as modified from the ISG Workstation, the Imatron Ultra Access Workstation is intended - as are the predicate devices — for receiving, manipulating, transmitting, storing, viewing, characterizing, comparing and enhancing high quality CT electronic images, as an aid in diagnosis, including for cardiac analysis, by a trained physician.
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/K972903 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972903: Imatron Ultra Access Workstation with Cardiac Software Extensions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972903
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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