510(k) · Cleared
Recalled · Class II · 2025DuraDiagnost
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Healthcare (Suzhou) Co., Ltd. · KPR System, X-Ray, Stationary
Cleared on Jul 9, 2020 as substantially equivalent to K141381 (Philips Healthcare (Suzhou) Co., Ltd., 2014) after a 23-day review. Its family tree reaches back 7 generations to 2000. It has been recalled 2 times.
- Decided
- Jul 9, 2020
- Review
- 23 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 7 generations to K001201 (2000). 22 ancestors in all, the oldest K862120 (1986). No later device cites it as a predicate yet.
- Root · 7 generations backK001201 Multix Compact K and Multix L Radiographic X-Ray SystemsSiemens Medical Solutions USA, Inc. · 2000
- 6 generations backK012546 Optima Urs Universal Radiographic SystemSedecal USA, Inc. · 2001 · Recalled
- 5 generations backK072659 Rad Vision, Models E and EUAlmana Medical Imaging · 2007
- 4 generations backK082064 Radvision ET Diagnostic X-Ray SystemAlmana Medical Imaging · 2008
- 3 generations backK083109 Suinsa Diagnostic X-Ray SystemSuinsa · 2008
- 2 generations backK123005 Ddrversa MotionSwissray Medical AG · 2012
- 1 generation backK141381 DuradiagnostPhilips Healthcare (Suzhou) Co., Ltd. · 2014 · Recalled
- This deviceK201640 DuraDiagnostPhilips Healthcare (Suzhou) Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001201 | Multix Compact K and Multix L Radiographic X-Ray Systems | Siemens Medical Solutions USA, Inc. | 2000 | — |
| −6 | K012546 | Optima Urs Universal Radiographic System | Sedecal USA, Inc. | 2001 | 2 |
| −5 | K072659 | Rad Vision, Models E and EU | Almana Medical Imaging | 2007 | — |
| −4 | K082064 | Radvision ET Diagnostic X-Ray System | Almana Medical Imaging | 2008 | — |
| −3 | K083109 | Suinsa Diagnostic X-Ray System | Suinsa | 2008 | — |
| −2 | K123005 | Ddrversa Motion | Swissray Medical AG | 2012 | — |
| −1 | K141381 | Duradiagnost | Philips Healthcare (Suzhou) Co., Ltd. | 2014 | 7 |
| 0 (this device) | K201640 | DuraDiagnost | Philips Healthcare (Suzhou) Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K141381 | DuradiagnostSummary page 4…Philips Healthcare (Suzhou) Co., Ltd. 510(k) Clearance: K141381-June 12, 2014 Classification Regulation: 21 CFR, Part 892.1680 Clas… | 2014 |
| † | K191813 | MobileDiagnost wDR 2.2 | 2019 |
| † | K153318 | Philips Eleva Workspot with SkyFlow | 2015 |
| † | K182973 | DigitalDiagnost C90 | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 10, 2025 | Class II | Z-1553-2025 | Under Investigation by firm | Potential for collimator to fall as a result of incorrect installation. |
| Mar 10, 2025 | Class II | Z-1554-2025 | Under Investigation by firm | Potential for collimator to fall as a result of incorrect installation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 8 of the 22 ancestors have a recall of any class.
- 1 other device also cites its predicate K141381.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201640 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201640: DuraDiagnost.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201640
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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