510(k) · Cleared
CleareduDR 380i Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai United Imaging Healthcare Co., Ltd. · IZL System, X-Ray, Mobile
Cleared on Oct 10, 2024 as substantially equivalent to K222339 (Shanghai United Imaging Healthcare Co., Ltd., 2022) after a 48-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Oct 10, 2024
- Review
- 48 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K041763 (2004). No later device cites it as a predicate yet.
- Root · 4 generations backK041763 Shimadzu Mobile X-Ray System Mux-100D SeriesShimadzu Corp. · 2004 · Recalled
- 3 generations backK120062 DRX-Revolution Mobile X-Ray SystemCarestream Health, Inc. · 2012 · Recalled
- 2 generations backK191025 DRX-Revolution Mobile X-ray SystemCarestream Health, Inc. · 2019 · Recalled
- 1 generation backK222339 uDR 380i ProShanghai United Imaging Healthcare Co., Ltd. · 2022
- This deviceK242515 uDR 380i ProShanghai United Imaging Healthcare Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K041763 | Shimadzu Mobile X-Ray System Mux-100D Series | Shimadzu Corp. | 2004 | 1 |
| −3 | K120062 | DRX-Revolution Mobile X-Ray System | Carestream Health, Inc. | 2012 | 7 |
| −2 | K191025 | DRX-Revolution Mobile X-ray System | Carestream Health, Inc. | 2019 | 2 |
| −1 | K222339 | uDR 380i Pro | Shanghai United Imaging Healthcare Co., Ltd. | 2022 | — |
| 0 (this device) | K242515 | uDR 380i Pro | Shanghai United Imaging Healthcare Co., Ltd. | 2024 | — |
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 |
|---|---|---|---|
| * | K222339 | uDR 380i ProSummary page 5…n Number: 21 CFR 892.1720 Review Panel: Radiology 4. Identification of Predicate Device(s) Predicate Device Trade Name: uDR 380i Pro 510(k) Number: K222339 Device Name: Mobile Digital Medical X-ray Imaging System Manufacturer:Shanghai United Imaging Healthcare Co.,Ltd. Re… | 2022 |
| † | K230175 | Digital Radiography CXDI-CS01 | 2023 |
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 20 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 3 of the 4 ancestors have a recall of any class.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
uDR 380i Pro is a mobile digital radiography device intended to acquire X-ray images of the human anatomy for medical diagnosis. uDR 380i Pro can be used on both adult and pediatric patient by a qualified and trained operator. This device is not intended for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242515: uDR 380i Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242515
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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