510(k) · Cleared
ClearedPortable DR Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shantou Institute of Ultrasonic Instruments Co., Ltd. · IZL System, X-Ray, Mobile
Cleared on Jun 18, 2026 as substantially equivalent to K202353 (Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui), 2020) after a 269-day review. Its family tree reaches back 13 generations to 1990.
- Decided
- Jun 18, 2026
- Review
- 269 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K896095 (1990). 25 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 9 generations between
- 3 generations backK191451 CMDR 2CW (Multiple models)Minxray, Inc. · 2019
- 2 generations backK200726 AcuityPDRRadmedix, LLC · 2020
- 1 generation backK202353 SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2020
- This deviceK253058 Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. · 2026
Show all 13 generations
- Root · 13 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 12 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 11 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 10 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 9 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 8 generations backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- 7 generations backK091364 Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009
- 6 generations backK100449 Minxray Model CMDR-2SMinxray, Inc. · 2010
- 5 generations backK141885 CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc. · 2014
- 4 generations backK171353 CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc. · 2017
- 3 generations backK191451 CMDR 2CW (Multiple models)Minxray, Inc. · 2019
- 2 generations backK200726 AcuityPDRRadmedix, LLC · 2020
- 1 generation backK202353 SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2020
- This deviceK253058 Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −12 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −11 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −10 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −9 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −8 | K070618 | Dicompacs, Model 5 | Oehm Und Rehbein GmbH | 2007 | — |
| −7 | K091364 | Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4 | Oehm Und Rehbein GmbH | 2009 | — |
| −6 | K100449 | Minxray Model CMDR-2S | Minxray, Inc. | 2010 | — |
| −5 | K141885 | CMDR-2ST & CMDR-2SLWT Digital Portable X-Ray | Minxray, Inc. | 2014 | — |
| −4 | K171353 | CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris | Minxray, Inc. | 2017 | — |
| −3 | K191451 | CMDR 2CW (Multiple models) | Minxray, Inc. | 2019 | — |
| −2 | K200726 | AcuityPDR | Radmedix, LLC | 2020 | — |
| −1 | K202353 | SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2020 | — |
| 0 (this device) | K253058 | Portable DR Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K202353 | SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging SystemSummary page 5…y system (21 CFR 892.1720) Regulatory Class: II Product Code: IZL, MQB, LLZ 3. Predicate Device Name of Device: SR-2300 Portable DR Imaging System (K202353) 510(k) holder: SIUI Regulation Name: Mobile x-ray system (21 CFR 892.1720) Regulatory Class: II… | 2020 |
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 36 years and passes through 8 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 25 ancestors have a recall of any class.
- 1 other device also cites its predicate K202353.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Portable DR Imaging System 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 extremities.
This device is not intended for mammography.
This device is only intended for adults, not for paediatric application.
This device is only suitable for stand-mounted use in hospital shielded rooms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253058 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253058: Portable DR Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253058
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026