510(k) · Cleared
ClearedAngio-CT Miyabi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IXI Block, Beam-Shaping, Radiation Therapy
Cleared on Apr 5, 1999 after a 47-day review. The FDA summary names its predicate without a number. 33 later devices descend from it.
- Decided
- Apr 5, 1999
- Review
- 47 days
- Class
- Class II
- Product code
- IXI
- Recalls
- None
- Predicates
- 0
33 later devices descend from it, 2 citing it directly.
- This deviceK990491 Angio-CT MiyabiSiemens Medical Solutions USA, Inc. · 1999
- Descendant · cites it directly · 32 of its ownK991600 Somatom Plus 4 with Sliding Gantry OptionSiemens Corp. · 1999
- Descendant · 2 generations on · 27 of its ownK051765 Ceretom, Model NL3000Neurologica Corporation · 2005
- Descendant · 3 generations on · 10 of its ownK090811 Inspira HD, Model: NL1000Neurologica Corporation · 2009
- Descendant · 3 generations on · 9 of its ownK102677 Bodytom NL 4000Neurologica Corporation · 2011
- Descendant · 3 generations on · 6 of its ownK171183 OmniTomNeurologica Corporation · 2017 · Recalled
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K991600Somatom Plus 4 with Sliding Gantry OptionSiemens Corp. · 1999 · cites it directly32descendants
- K051765Ceretom, Model NL3000Neurologica Corporation · 2005 · 2 generations on27descendants
- K090811Inspira HD, Model: NL1000Neurologica Corporation · 2009 · 3 generations on10descendants
- K102677Bodytom NL 4000Neurologica Corporation · 2011 · 3 generations on9descendants
- K171183OmniTomNeurologica Corporation · 2017 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990491 | Angio-CT Miyabi | Siemens Medical Solutions USA, Inc. | 1999 | — |
| +1 | K991600 | Somatom Plus 4 with Sliding Gantry Option | Siemens Corp. | 1999 | — |
| +2 | K051765 | Ceretom, Model NL3000 | Neurologica Corporation | 2005 | — |
| +3 | K090811 | Inspira HD, Model: NL1000 | Neurologica Corporation | 2009 | — |
| +3 | K102677 | Bodytom NL 4000 | Neurologica Corporation | 2011 | — |
| +3 | K171183 | OmniTom | Neurologica Corporation | 2017 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 IXI? 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 IXI device
- #1 K253025 Ricoh 3D for Healthcare Bolusscore 12.9 · 7 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 |
|---|---|---|---|
| * | — | SOMATOM Plus 4 Named without a submission number | |
| * | — | Multistar Plus systems with Koordinat M Named without a submission number |
What descends from it? (33)
See all 332 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, K991600 (Siemens Corp., 1999) has gone furthest, with 32 descendants of its own.
How does its category compare?
All IXI devicesIXI Block, Beam-Shaping, Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IXI
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · IXI
90in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IXI
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IXI
1in 2016
MAUDE reports naming product code IXI, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 3 | 78 | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 2 | — | 1 | 28 |
| 2012 | 1 | — | 1 | 3 |
| 2013 | 3 | 90 | 2 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SOMATOM Plus 4 is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous movement of the sliding gantry.) The Multistar Plus is a ceiling-suspended double C-arm for single…
Read the full statement (128 words)
The SOMATOM Plus 4 is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous movement of the sliding gantry.)
The Multistar Plus is a ceiling-suspended double C-arm for single plane general vascular imaging as well as interventional techniques.
Angio-CT MIYABI is a combined system, which allows interventional radiological techniques, and whole body x-ray computed tomography scanning on a single patient without moving the patient from one table to another especially after or during interventional procedure performed under image intensified visualization (e.g. stenting, coiling, local chemical therapy, embolization).
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/K990491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990491: Angio-CT Miyabi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990491
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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