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 Jun 12, 2014 as substantially equivalent to K103448 (Ge Medical Systems, LLC, 2011) and 2 other predicates after a 16-day review. Its family tree reaches back 6 generations to 2000. 3 later devices descend from it. It has been recalled 7 times.
- Decided
- Jun 12, 2014
- Review
- 16 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 7
- Predicates
- 3
Its longest line of descent runs back 6 generations to K001201 (2000). 21 ancestors in all, the oldest K862120 (1986). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK001201 Multix Compact K and Multix L Radiographic X-Ray SystemsSiemens Medical Solutions USA, Inc. · 2000
- 5 generations backK012546 Optima Urs Universal Radiographic SystemSedecal USA, Inc. · 2001 · Recalled
- 4 generations backK072659 Rad Vision, Models E and EUAlmana Medical Imaging · 2007
- 3 generations backK082064 Radvision ET Diagnostic X-Ray SystemAlmana Medical Imaging · 2008
- 2 generations backK083109 Suinsa Diagnostic X-Ray SystemSuinsa · 2008
- 1 generation backK123005 Ddrversa MotionSwissray Medical AG · 2012
- This deviceK141381 DuradiagnostPhilips Healthcare (Suzhou) Co., Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK163410 DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK201725 DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Lit. · 2020 · Recalled
- Descendant · cites it directly · 0 of its ownK201640 DuraDiagnostPhilips Healthcare (Suzhou) Co., Ltd. · 2020 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001201 | Multix Compact K and Multix L Radiographic X-Ray Systems | Siemens Medical Solutions USA, Inc. | 2000 | — |
| −5 | K012546 | Optima Urs Universal Radiographic System | Sedecal USA, Inc. | 2001 | 2 |
| −4 | K072659 | Rad Vision, Models E and EU | Almana Medical Imaging | 2007 | — |
| −3 | K082064 | Radvision ET Diagnostic X-Ray System | Almana Medical Imaging | 2008 | — |
| −2 | K083109 | Suinsa Diagnostic X-Ray System | Suinsa | 2008 | — |
| −1 | K123005 | Ddrversa Motion | Swissray Medical AG | 2012 | — |
| 0 (this device) | K141381 | Duradiagnost | Philips Healthcare (Suzhou) Co., Ltd. | 2014 | — |
| +1 | K163410 | DigitalDiagnost C50 | Philips Healthcare (Suzhou) Co., Ltd. | 2017 | 4 |
| +2 | K201725 | DigitalDiagnost C50 | Philips Healthcare (Suzhou) Co., Lit. | 2020 | 3 |
| +1 | K201640 | DuraDiagnost | Philips Healthcare (Suzhou) Co., Ltd. | 2020 | 2 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K103448 | Brivo XR385Summary page 1…Radiographic System Manufacturer: GE MEDICAL SYSTEM, LCC 510(k) Clearance: K 103448 (August 12, 2011) Classification 21 CFR, Part 892.1680 Regulation:… | 2011 |
| * | K982795 | Philips Bucky VisionSummary page 2…Philips BuckyVision 2: Manufacturer: Philips Medical Systems, Inc. 5 10O(k) Clearance: K982795 (November 24,1998) Classification 2ICFR §892.1680 Regulation:… | 1998 |
| * | K123005 | Ddrversa MotionSummary page 2…rade Name: ddRVersaTM Motion 3: Manufacturer: Swissray Medical AG 510(k) Clearance: K 123005 (December 7, 2012) Classification 2I1CFR §892.1680 Regulation:… | 2012 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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. |
| May 31, 2017 | Class II | Z-2322-2017 | Device Design | Tube arm assembly could fall down due to cracked welding joints |
| Nov 10, 2015 | Class II | Z-1696-2016 | Radiation Control for Health and Safety Act | The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image. |
| Sep 17, 2015 | Class II | Z-2682-2016 | Radiation Control for Health and Safety Act | Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing… |
| Feb 9, 2015 | Class II | Z-1555-2015 | Software design (manufacturing process) | The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j). |
| Jan 23, 2015 | Class II | Z-1251-2015 | Process control | Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installation of table may cause it to float. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 7 of the 21 ancestors have a recall of any class.
- Of its descendants, K163410 (Philips Healthcare (Suzhou) Co., Ltd., 2017) has gone furthest, with 1 descendant 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. 2014, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141381: Duradiagnost.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141381
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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