510(k) · Cleared
ClearedDigiscan 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IXK System, Imaging, X-Ray, Electrostatic
Cleared on Dec 17, 1992 after a 106-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 194 later devices descend from it.
- Decided
- Dec 17, 1992
- Review
- 106 days
- Class
- Class II
- Product code
- IXK
- Recalls
- None
- Predicates
- 0
194 later devices descend from it, 3 citing it directly.
- This deviceK924459 Digiscan 2Siemens Medical Solutions USA, Inc. · 1992
- Descendant · cites it directly · 187 of its ownK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 103 of its ownK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- Descendant · 2 generations on · 81 of its ownK013826 Axiom Aristos FX (Multi Purpose Radiography System)Siemens Medical Systems, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 80 of its ownK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 4 generations on · 78 of its ownK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
Showing 5 of 194 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 194 · See all- K983732Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · cites it directly187descendants
- K992794Stingray DR, Model 1Infimed, Inc. · 1999 · 2 generations on103descendants
- K013826Axiom Aristos FX (Multi Purpose Radiography System)Siemens Medical Systems, Inc. · 2002 · 2 generations on81descendants
- K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · 3 generations on80descendants
- K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · 4 generations on78descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924459 | Digiscan 2 | Siemens Medical Solutions USA, Inc. | 1992 | — |
| +1 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| +2 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| +2 | K013826 | Axiom Aristos FX (Multi Purpose Radiography System) | Siemens Medical Systems, Inc. | 2002 | 8 |
| +3 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| +4 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 8 | 0 |
| 2011 | 10 | 0 |
| 2012 | 7 | 0 |
| 2013 | 11 | 0 |
| 2014 | 12 | 0 |
| 2015 | 12 | 0 |
| 2016 | 13 | 0 |
| 2017 | 10 | 0 |
| 2018 | 8 | 0 |
| 2019 | 14 | 0 |
| 2020 | 12 | 0 |
| 2021 | 14 | 0 |
| 2022 | 9 | 0 |
| 2023 | 7 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 0 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IXK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (194)
See all 1943 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?
- Of its descendants, K983732 (Siemens Medical Solutions USA, Inc., 1999) has gone furthest, with 187 descendants of its own.
How does its category compare?
All IXK devicesIXK System, Imaging, X-Ray, Electrostatic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IXK
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · IXK
Too few IXK 510(k)s in any year since 2007 to give a median.
Recalls per year · IXK
No recall names IXK since 2007.
Adverse event reports per year · IXK
No MAUDE report names IXK since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K924459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924459: Digiscan 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924459
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026