510(k) · Cleared
ClearedDigital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Sontu Medical Imaging Equipment Co., Ltd. · KPR System, X-Ray, Stationary
Cleared on Jan 6, 2025 as substantially equivalent to K220919 (Siemens Medical Solutions USA, Inc., 2022) and 1 other predicate after a 137-day review. Its family tree reaches back 16 generations to 1980.
- Decided
- Jan 6, 2025
- Review
- 137 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K801623 (1980). 74 ancestors in all. No later device cites it as a predicate yet.
- Root · 16 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 12 generations between
- 3 generations backK193089 MULTIX ImpactSiemens Medical Solutions USA, Inc. · 2020
- 2 generations backK203340 MULTIX Impact CSiemens Medical Solutions USA, Inc. · 2021
- 1 generation backK213700 MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc. · 2021
- This deviceK242499 Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars…Shenzhen Sontu Medical Imaging Equipment Co., Ltd. · 2025
Show all 16 generations
- Root · 16 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 15 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 14 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 13 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 12 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 11 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 10 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 9 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 8 generations backK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 7 generations backK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- 6 generations backK142049 Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc. · 2014
- 5 generations backK162971 Multix Fusion MaxSiemens Medical Solutions USA, Inc. · 2016
- 4 generations backK182517 MULTIX ImpactSiemens Medi Cal Solutions, Inc. · 2019
- 3 generations backK193089 MULTIX ImpactSiemens Medical Solutions USA, Inc. · 2020
- 2 generations backK203340 MULTIX Impact CSiemens Medical Solutions USA, Inc. · 2021
- 1 generation backK213700 MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc. · 2021
- This deviceK242499 Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars…Shenzhen Sontu Medical Imaging Equipment Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −15 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −14 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −13 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −12 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −11 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −10 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −9 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| −8 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
| −7 | K121513 | Multix Fusion | Siemens Medical Solution | 2012 | 4 |
| −6 | K142049 | Multix Fusion VA30 & VA40 | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −5 | K162971 | Multix Fusion Max | Siemens Medical Solutions USA, Inc. | 2016 | — |
| −4 | K182517 | MULTIX Impact | Siemens Medi Cal Solutions, Inc. | 2019 | — |
| −3 | K193089 | MULTIX Impact | Siemens Medical Solutions USA, Inc. | 2020 | — |
| −2 | K203340 | MULTIX Impact C | Siemens Medical Solutions USA, Inc. | 2021 | — |
| −1 | K213700 | MULTIX Impact, MULTIX Impact C | Siemens Medical Solutions USA, Inc. | 2021 | — |
| 0 (this device) | K242499 | Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) | Shenzhen Sontu Medical Imaging Equipment Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 13 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 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 |
|---|---|---|---|
| * | K220919 | MULTIX Impact ESummary page 6…KPR, MQB 4. PREDICATE DEVICE 1 / 10 Device Name: Digital Radiography X-ray System (K220919, MULTIX Impact E VB10 K213700, MULTIX Impact (VA21)) Common name: Stationary x-ray syste… | 2022 |
| * | K213700 | MULTIX Impact, MULTIX Impact CSummary page 6…1 / 10 Device Name: Digital Radiography X-ray System (K220919, MULTIX Impact E VB10 K213700, MULTIX Impact (VA21)) Common name: Stationary x-ray system Regulation number 21 CFR 892.1680 Regul… | 2021 |
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 45 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 21 of the 74 ancestors have a recall of any class.
- 1 other device also cites its predicate K220919.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
The Digital radiography X-ray system is used in hospitals, clinics, and medical practices.
The Digital radiography X-ray system enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. It is not intended for mammographic applications.
The Digital radiography X-ray system uses digital detectors for generating diagnostic images by converting X-rays into image signals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242499 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242499: Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242499
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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