510(k) · Cleared
ClearedSirius Starmobile tiara
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Medical Systems America, Inc. · IZL System, X-Ray, Mobile
Cleared on Mar 6, 2015 as substantially equivalent to K120062 (Carestream Health, Inc., 2012) after an 81-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it.
- Decided
- Mar 6, 2015
- Review
- 81 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K041763 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK041763 Shimadzu Mobile X-Ray System Mux-100D SeriesShimadzu Corp. · 2004 · Recalled
- 1 generation backK120062 DRX-Revolution Mobile X-Ray SystemCarestream Health, Inc. · 2012 · Recalled
- This deviceK143537 Sirius Starmobile tiaraHitachi Medical Systems America, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK170858 FDR Aqro (DR-XD 1000)Fujifilm Medical Systems U.S.A, Inc. · 2017 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K170858FDR Aqro (DR-XD 1000)Fujifilm Medical Systems U.S.A, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K041763 | Shimadzu Mobile X-Ray System Mux-100D Series | Shimadzu Corp. | 2004 | 1 |
| −1 | K120062 | DRX-Revolution Mobile X-Ray System | Carestream Health, Inc. | 2012 | 7 |
| 0 (this device) | K143537 | Sirius Starmobile tiara | Hitachi Medical Systems America, Inc. | 2015 | — |
| +1 | K170858 | FDR Aqro (DR-XD 1000) | Fujifilm Medical Systems U.S.A, Inc. | 2017 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 IZL? 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 IZL device
- #1 K242015 TOPAZ Mobile X-ray System (Models : TOPAZ-32D…score 19.9 · 19 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 |
|---|---|---|---|
| * | K120062 | DRX-Revolution Mobile X-Ray SystemSummary page 4…stem, X-ray, Mobile Trade/Proprietary Name: Sirius Starmobile tiara System Predicate Device(s): Carestream DRX-Revolution Mobile X-ray System (K120062) Device Intended Use The Mobile X-ray Unit Sirius Starmobile tiara is a general radiography system and is composed of the X-ray… | 2012 |
| † | K132509 | FDR D-Evo Flat Panel Detector System | 2013 |
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 |
|---|---|---|---|
| K170858 | FDR Aqro (DR-XD 1000) | 2017 | 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 11 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K170858 (Fujifilm Medical Systems U.S.A, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K120062.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · IZL
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZL
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZL
47in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZL
27in 2025
MAUDE reports naming product code IZL, 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 | 3 | 30 | 7 | 16 |
| 2008 | 4 | 49 | 0 | 27 |
| 2009 | 3 | 125 | 0 | 35 |
| 2010 | 3 | 65 | 4 | 75 |
| 2011 | 6 | 66 | 6 | 118 |
| 2012 | 3 | 83 | 5 | 24 |
| 2013 | 0 | — | 10 | 17 |
| 2014 | 7 | 104 | 4 | 51 |
| 2015 | 4 | 88 | 4 | 30 |
| 2016 | 6 | 47 | 0 | 33 |
| 2017 | 7 | 45 | 0 | 35 |
| 2018 | 8 | 47 | 0 | 27 |
| 2019 | 9 | 33 | 2 | 40 |
| 2020 | 9 | 43 | 1 | 48 |
| 2021 | 13 | 48 | 0 | 47 |
| 2022 | 16 | 89 | 1 | 32 |
| 2023 | 3 | 55 | 6 | 77 |
| 2024 | 9 | 159 | 5 | 39 |
| 2025 | 11 | 153 | 47 | 27 |
| 2026 | 6 | 157 | 5 | — |
What is it indicated for?
The Mobile X-ray Unit Sirius Starmobile tiara is a general radiography system and is composed of the X-ray high voltage generator, X-ray tube, support unit, and digital radiograph device (DR-ID 800) made by Fujifilm Corporation.
This device is designed for pediatric and adult patients.
It is intended for use in general radiography of the head, body, or extremities including pediatric exams. The device output can provide an aid to diagnosis when used by a qualified physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143537 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143537: Sirius Starmobile tiara.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143537
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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