510(k) · Cleared
Recalled · Class II · 2025DigitalDiagnost
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Dmc GmbH · KPR System, X-Ray, Stationary
Cleared on Apr 2, 2021 as substantially equivalent to K202564 (Philips Medical Systems Dmc GmbH, 2020) after a 25-day review. Its family tree reaches back 11 generations to 1981. 1 later device descends from it. It has been recalled 8 times.
- Decided
- Apr 2, 2021
- Review
- 25 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 11 generations to K803130 (1981). 31 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 7 generations between
- 3 generations backK141736 Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH · 2014 · Recalled
- 2 generations backK182973 DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2019
- 1 generation backK202564 DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2020 · Recalled
- This deviceK210692 DigitalDiagnostPhilips Medical Systems Dmc GmbH · 2021
- Descendant · cites it directly · 0 of its ownK212186 Philips Radiology Smart AssistantPhilips Medical Systems Dmc GmbH · 2021
Show all 11 generations
- Root · 11 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 10 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 9 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 8 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 7 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 6 generations backK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
- 5 generations backK122736 DX-D Imaging PackageAgfa Healthcare N.V. · 2013
- 4 generations backK140771 Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014
- 3 generations backK141736 Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH · 2014 · Recalled
- 2 generations backK182973 DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2019
- 1 generation backK202564 DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2020 · Recalled
- This deviceK210692 DigitalDiagnostPhilips Medical Systems Dmc GmbH · 2021
Most influential descendants
Showing 1 of 1 · See all- K212186Philips Radiology Smart AssistantPhilips Medical Systems Dmc GmbH · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −10 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −9 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −8 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −7 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −6 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
| −5 | K122736 | DX-D Imaging Package | Agfa Healthcare N.V. | 2013 | — |
| −4 | K140771 | Philips Eleva Workspot | Philips Medical Systems Dmc GmbH | 2014 | — |
| −3 | K141736 | Philips Prograde; Philips Eleva Workspot for Digital Diagnost | Philips Medical Systems Dmc GmbH | 2014 | 6 |
| −2 | K182973 | DigitalDiagnost C90 | Philips Medical Systems Dmc GmbH | 2019 | — |
| −1 | K202564 | DigitalDiagnost C90 | Philips Medical Systems Dmc GmbH | 2020 | 8 |
| 0 (this device) | K210692 | DigitalDiagnost | Philips Medical Systems Dmc GmbH | 2021 | — |
| +1 | K212186 | Philips Radiology Smart Assistant | Philips Medical Systems Dmc GmbH | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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.
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 |
|---|---|---|---|
| K212186 | Philips Radiology Smart Assistant | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 1, 2025 | Class II | Z-0464-2026 | Device Design | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to… |
| Sep 21, 2023 | Class II | Z-0277-2024 | Under Investigation by firm | Potential for units suspended on the ceiling to fail and fall. |
| Sep 21, 2023 | Class II | Z-0272-2024 | Under Investigation by firm | Potential for units suspended on the ceiling to fail and fall. |
| Sep 21, 2023 | Class II | Z-0278-2024 | Under Investigation by firm | Potential for units suspended on the ceiling to fail and fall. |
| Sep 21, 2023 | Class II | Z-0273-2024 | Under Investigation by firm | Potential for units suspended on the ceiling to fail and fall. |
| Sep 21, 2023 | Class II | Z-0274-2024 | Under Investigation by firm | Potential for units suspended on the ceiling to fail and fall. |
| May 19, 2021 | Class II | Z-1327-2022 | Radiation Control for Health and Safety Act | 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 image on the first examination due to an issue in the firmware of the… |
| May 19, 2021 | Class II | Z-1326-2022 | Radiation Control for Health and Safety Act | 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 image on the first examination due to an issue in the firmware of the… |
The 5 latest of 8 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 40 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 18 of the 31 ancestors have a recall of any class.
- Of its descendants, K212186 (Philips Medical Systems Dmc GmbH, 2021) has gone furthest, with 0 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. 2021, 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 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography
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/K210692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210692: DigitalDiagnost.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210692
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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