510(k) · Cleared
ClearedAdmire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medi Cal Solutions, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Jun 29, 2016 as substantially equivalent to K133646 (Siemens Medical Systems, Inc., 2014) after a 222-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Jun 29, 2016
- Review
- 222 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K013561 (2001). 12 ancestors in all, the oldest K982349 (1998). No later device cites it as a predicate yet.
- Root · 7 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 6 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 5 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 4 generations backK052216 Somatom DefinitionSiemens Medical Systems, Inc. · 2005
- 3 generations backK082220 Somatom Flash DSSiemens Medical Solutions USA, Inc. · 2008
- 2 generations backK103424 SafireSiemens Medical Solutions USA, Inc. · 2011
- 1 generation backK133646 AdmireSiemens Medical Systems, Inc. · 2014
- This deviceK153360 AdmireSiemens Medi Cal Solutions, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −6 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −5 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −4 | K052216 | Somatom Definition | Siemens Medical Systems, Inc. | 2005 | — |
| −3 | K082220 | Somatom Flash DS | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −2 | K103424 | Safire | Siemens Medical Solutions USA, Inc. | 2011 | — |
| −1 | K133646 | Admire | Siemens Medical Systems, Inc. | 2014 | — |
| 0 (this device) | K153360 | Admire | Siemens Medi Cal Solutions, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K133646 | AdmireSummary page 5…iption ADMIRE is an iterative reconstruction option designed to be used on Siemens currently marketed and future CT devices. Its use has been previously cleared by FDA (K 133646, clearance date June 20, 2014). No modifications were made to the algorithm or to the implementation of the feature. The changes… | 2014 |
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 15 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 6 of the 12 ancestors have a recall of any class.
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. 2016, this device’s year, is highlighted.
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?
ADMIRE is a CT reconstruction software. The end user can choose to apply either ADMIRE or the weighted filter back-projection (WFBP) to the acquired raw data. Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of ADMIRE can help to reduce radiation dose while maintaining pixel noise, low contrast detectability and high contrast resolution. Phantom measurements showed that high contrast resolution is…
Read the full statement (123 words)
ADMIRE is a CT reconstruction software. The end user can choose to apply either ADMIRE or the weighted filter back-projection (WFBP) to the acquired raw data. Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of ADMIRE can help to reduce radiation dose while maintaining pixel noise, low contrast detectability and high contrast resolution.
Phantom measurements showed that high contrast resolution is equivalent or improved and pixel noise is equivalent between full dose WFBP images and reduced dose ADMIRE images. Additionally, ADMIRE can reduce spiral artifacts by using iterations going back and forth between image space and raw data space.
Images reconstructed with ADMIRE are not intended to be evaluated with syngo Osteo CT or syngo Calcium Scoring.
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/K153360 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153360: Admire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153360
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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