510(k) · Cleared
ClearedAccuimage Smartgate Upgrade
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accuimage Diagnostics Corp. · JAK System, X-Ray, Tomography, Computed
Cleared on Sep 25, 2001 as substantially equivalent to K980169 (General Electric Co., 1998) and 1 other predicate after an 81-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Sep 25, 2001
- Review
- 81 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K980169 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK980169 Hispeed LX//I, Hispeed FX/I, and Hispeed DX/I Family of SystemsGeneral Electric Co. · 1998 · Recalled
- This deviceK012106 Accuimage Smartgate UpgradeAccuimage Diagnostics Corp. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980169 | Hispeed LX//I, Hispeed FX/I, and Hispeed DX/I Family of Systems | General Electric Co. | 1998 | 2 |
| 0 (this device) | K012106 | Accuimage Smartgate Upgrade | Accuimage Diagnostics Corp. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K980169 | Hispeed LX//I, Hispeed FX/I, and Hispeed DX/I Family of SystemsSummary page 3…Manufacturer GE Medical Vital Images Acculmage Systems Product HiSpeed LX/i Vscore with Acculmage Name with SmartScore AutoGate option Smartgate Upgrade 510(k) o Number K980169 K003230 Computer PC / Windows Pentium / Windows Platform Not Known workstation workstation Gating Option Match cardiac CT Match c… | 1998 |
| * | K003230 | V Score with Auto Gate Model TBDSummary page 3…turer GE Medical Vital Images Acculmage Systems Product HiSpeed LX/i Vscore with Acculmage Name with SmartScore AutoGate option Smartgate Upgrade 510(k) o Number K980169 K003230 Computer PC / Windows Pentium / Windows Platform Not Known workstation workstation Gating Option Match cardiac CT Match cardiac C… | 2000 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K980169.
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?
Heart calcium scoring for gated CT images to minimize effects of heart movements.
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/K012106 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012106: Accuimage Smartgate Upgrade.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012106
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026