510(k) · Cleared
ClearedSuinsa Diagnostic X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suinsa · KPR System, X-Ray, Stationary
Cleared on Dec 4, 2008 as substantially equivalent to K082064 (Almana Medical Imaging, 2008) after a 45-day review. Its family tree reaches back 4 generations to 2000. 5 later devices descend from it.
- Decided
- Dec 4, 2008
- Review
- 45 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001201 (2000). 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK001201 Multix Compact K and Multix L Radiographic X-Ray SystemsSiemens Medical Solutions USA, Inc. · 2000
- 3 generations backK012546 Optima Urs Universal Radiographic SystemSedecal USA, Inc. · 2001 · Recalled
- 2 generations backK072659 Rad Vision, Models E and EUAlmana Medical Imaging · 2007
- 1 generation backK082064 Radvision ET Diagnostic X-Ray SystemAlmana Medical Imaging · 2008
- This deviceK083109 Suinsa Diagnostic X-Ray SystemSuinsa · 2008
- Descendant · cites it directly · 4 of its ownK123005 Ddrversa MotionSwissray Medical AG · 2012
- Descendant · 2 generations on · 3 of its ownK141381 DuradiagnostPhilips Healthcare (Suzhou) Co., Ltd. · 2014 · Recalled
- Descendant · 3 generations on · 1 of its ownK163410 DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. · 2017 · Recalled
- Descendant · 4 generations on · 0 of its ownK201725 DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Lit. · 2020 · Recalled
- Descendant · 3 generations on · 0 of its ownK201640 DuraDiagnostPhilips Healthcare (Suzhou) Co., Ltd. · 2020 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K123005Ddrversa MotionSwissray Medical AG · 2012 · cites it directly4descendants
- K141381DuradiagnostPhilips Healthcare (Suzhou) Co., Ltd. · 2014 · 2 generations on3descendants
- K163410DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. · 2017 · 3 generations on1descendant
- K201725DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Lit. · 2020 · 4 generations on0descendants
- K201640DuraDiagnostPhilips Healthcare (Suzhou) Co., Ltd. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001201 | Multix Compact K and Multix L Radiographic X-Ray Systems | Siemens Medical Solutions USA, Inc. | 2000 | — |
| −3 | K012546 | Optima Urs Universal Radiographic System | Sedecal USA, Inc. | 2001 | 2 |
| −2 | K072659 | Rad Vision, Models E and EU | Almana Medical Imaging | 2007 | — |
| −1 | K082064 | Radvision ET Diagnostic X-Ray System | Almana Medical Imaging | 2008 | — |
| 0 (this device) | K083109 | Suinsa Diagnostic X-Ray System | Suinsa | 2008 | — |
| +1 | K123005 | Ddrversa Motion | Swissray Medical AG | 2012 | — |
| +2 | K141381 | Duradiagnost | Philips Healthcare (Suzhou) Co., Ltd. | 2014 | 7 |
| +3 | K163410 | DigitalDiagnost C50 | Philips Healthcare (Suzhou) Co., Ltd. | 2017 | 4 |
| +4 | K201725 | DigitalDiagnost C50 | Philips Healthcare (Suzhou) Co., Lit. | 2020 | 3 |
| +3 | K201640 | DuraDiagnost | Philips Healthcare (Suzhou) Co., Ltd. | 2020 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 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? (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 |
|---|---|---|---|
| * | K082064 | Radvision ET Diagnostic X-Ray SystemSummary page 1…Code 90 KPR Common/Usual Name: General purpose diagnostic X-ray Unit. 2. Equivalent legally marketed devices: Ahmana Medical Radvision ET Diagnostic X-Ray Systems K082064 3.Indications for Use (intended use) This X-Ray System is intended for use by a qualified/trained doctor or technician on bo… | 2008 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123005 | Ddrversa Motion | 2012 | 4 |
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 8 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K123005 (Swissray Medical AG, 2012) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Suinsa Diagnostic X-Ray System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083109: Suinsa Diagnostic X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083109
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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