510(k) · Cleared
Recalled · Class II · 2023DigitalDiagnost C50
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 Jan 4, 2017 as substantially equivalent to K141381 (Philips Healthcare (Suzhou) Co., Ltd., 2014) after a 30-day review. Its family tree reaches back 7 generations to 2000. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Jan 4, 2017
- Review
- 30 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 7 generations to K001201 (2000). 22 ancestors in all, the oldest K862120 (1986). 1 later device descends from it, 1 citing it directly.
- 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 deviceK163410 DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK201725 DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Lit. · 2020 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K201725DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Lit. · 2020 · cites it directly0descendants
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) | K163410 | DigitalDiagnost C50 | Philips Healthcare (Suzhou) Co., Ltd. | 2017 | — |
| +1 | K201725 | DigitalDiagnost C50 | Philips Healthcare (Suzhou) Co., Lit. | 2020 | 3 |
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 |
|---|---|---|
| 2020 | 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? (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 6…Trade Name: DuraDiagnost Manufacturer: Philips Healthcare (Suzhou) Co., Ltd. 510(k) Clearance: K141381 (June 12, 2014) Classification 21 CFR, Part 892.1680 Regulation:… | 2014 |
| † | K161459 | Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201725 | DigitalDiagnost C50 | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 9, 2023 | Class II | Z-1383-2023 | Equipment maintenance | If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through normal wear and tear… |
| Mar 9, 2023 | Class II | Z-1382-2023 | Equipment maintenance | If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through normal wear and tear… |
| Feb 25, 2022 | Class II | Z-1563-2022 | Software Design Change | Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of the image on the first examination due to an issue in the firmware of the… |
| Dec 21, 2018 | Class II | Z-2498-2019 | Radiation Control for Health and Safety Act | During recent evaluations of the Philips DigitalDiagnost C50 system, Philips identified a missing label. This notification is intended to provide you with information regarding what the issue is, and relevant affected product, the actions… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 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.
- Of its descendants, K201725 (Philips Healthcare (Suzhou) Co., Lit., 2020) has gone furthest, with 0 descendants of its own.
- 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. 2017, 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 DigitalDiagnost C50 system 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/K163410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163410: DigitalDiagnost C50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163410
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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