510(k) · Cleared
ClearedAdmire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Systems, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Jun 20, 2014 as substantially equivalent to K103424 (Siemens Medical Solutions USA, Inc., 2011) after a 205-day review. Its family tree reaches back 6 generations to 2001. 1 later device descends from it.
- Decided
- Jun 20, 2014
- Review
- 205 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K013561 (2001). 11 ancestors in all, the oldest K982349 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 5 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 4 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 3 generations backK052216 Somatom DefinitionSiemens Medical Systems, Inc. · 2005
- 2 generations backK082220 Somatom Flash DSSiemens Medical Solutions USA, Inc. · 2008
- 1 generation backK103424 SafireSiemens Medical Solutions USA, Inc. · 2011
- This deviceK133646 AdmireSiemens Medical Systems, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK153360 AdmireSiemens Medi Cal Solutions, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K153360AdmireSiemens Medi Cal Solutions, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −5 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −4 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −3 | K052216 | Somatom Definition | Siemens Medical Systems, Inc. | 2005 | — |
| −2 | K082220 | Somatom Flash DS | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −1 | K103424 | Safire | Siemens Medical Solutions USA, Inc. | 2011 | — |
| 0 (this device) | K133646 | Admire | Siemens Medical Systems, Inc. | 2014 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K103424 | SafireSummary page 2…Class 11 Product Code: 90JAK Legally Marketed Predicate Devices Trade Name: SAF IRE 510(k)#: K103424 Clearance Date: November 22, 2011 Classification Name: System, X-Ray, Tomography, Computed Classi… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153360 | Admire | 2016 | 0 |
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 13 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 6 of the 11 ancestors have a recall of any class.
- Of its descendants, K153360 (Siemens Medi Cal Solutions, Inc., 2016) has gone furthest, with 0 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. 2014, 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 and pixel…
Read the full statement (119 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 and pixel noise are 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 as stated in the FDA summary.
https://510kreport.com/device/K133646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133646: Admire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133646
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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