510(k) · Cleared
ClearedSR-8100 Portable X-ray Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · IZL System, X-Ray, Mobile
Cleared on Jul 9, 2020 as substantially equivalent to K182207 (Minxray, Inc., 2018) after a 121-day review. Its family tree reaches back 3 generations to 2004. 1 later device descends from it.
- Decided
- Jul 9, 2020
- Review
- 121 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K040046 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK040046 Minxray, Model HF120/60H PowerplusMinxray, Inc. · 2004
- 2 generations backK153059 HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc. · 2016
- 1 generation backK182207 TR90BHMinxray, Inc. · 2018
- This deviceK200637 SR-8100 Portable X-ray UnitShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2020
- Descendant · cites it directly · 0 of its ownK241996 ULTRA 1040Ecoray Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K241996ULTRA 1040Ecoray Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K040046 | Minxray, Model HF120/60H Powerplus | Minxray, Inc. | 2004 | — |
| −2 | K153059 | HF1202H PowerPlus Portable X-ray Equipment | Minxray, Inc. | 2016 | — |
| −1 | K182207 | TR90BH | Minxray, Inc. | 2018 | — |
| 0 (this device) | K200637 | SR-8100 Portable X-ray Unit | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2020 | — |
| +1 | K241996 | ULTRA 1040 | Ecoray Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
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 |
|---|---|---|---|
| K241996 | ULTRA 1040 | 2025 | 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 16 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K241996 (Ecoray Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K182207.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 SR-8100 Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient’s anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities). The device may be used for handheld diagnostic imaging of body extremities. The system is subject to the following limitations of use when stand-mounted: The…
Read the full statement (122 words)
The SR-8100 Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient’s anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).
The device may be used for handheld diagnostic imaging of body extremities.
The system is subject to the following limitations of use when stand-mounted:
The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities.
The device may be used for imaging of the chest when used without a grid.
This device is not to be used on bariatric patients, unless imaging body extremities.
This device is not intended for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200637: SR-8100 Portable X-ray Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200637
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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