510(k) · Cleared
ClearedPhilips Radiology Smart Assistant
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 Dec 13, 2021 as substantially equivalent to K210692 (Philips Medical Systems Dmc GmbH, 2021) after a 153-day review. Its family tree reaches back 12 generations to 1981.
- Decided
- Dec 13, 2021
- Review
- 153 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K803130 (1981). 32 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 8 generations between
- 3 generations backK182973 DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2019
- 2 generations backK202564 DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2020 · Recalled
- 1 generation backK210692 DigitalDiagnostPhilips Medical Systems Dmc GmbH · 2021 · Recalled
- This deviceK212186 Philips Radiology Smart AssistantPhilips Medical Systems Dmc GmbH · 2021
Show all 12 generations
- Root · 12 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 11 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 10 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 9 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 8 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 7 generations backK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
- 6 generations backK122736 DX-D Imaging PackageAgfa Healthcare N.V. · 2013
- 5 generations backK140771 Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014
- 4 generations backK141736 Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH · 2014 · Recalled
- 3 generations backK182973 DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2019
- 2 generations backK202564 DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2020 · Recalled
- 1 generation backK210692 DigitalDiagnostPhilips Medical Systems Dmc GmbH · 2021 · Recalled
- This deviceK212186 Philips Radiology Smart AssistantPhilips Medical Systems Dmc GmbH · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −11 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −10 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −9 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −8 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −7 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
| −6 | K122736 | DX-D Imaging Package | Agfa Healthcare N.V. | 2013 | — |
| −5 | K140771 | Philips Eleva Workspot | Philips Medical Systems Dmc GmbH | 2014 | — |
| −4 | K141736 | Philips Prograde; Philips Eleva Workspot for Digital Diagnost | Philips Medical Systems Dmc GmbH | 2014 | 6 |
| −3 | K182973 | DigitalDiagnost C90 | Philips Medical Systems Dmc GmbH | 2019 | — |
| −2 | K202564 | DigitalDiagnost C90 | Philips Medical Systems Dmc GmbH | 2020 | 8 |
| −1 | K210692 | DigitalDiagnost | Philips Medical Systems Dmc GmbH | 2021 | 8 |
| 0 (this device) | 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 |
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?
No later submission names this one as a predicate yet.
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 40 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 19 of the 32 ancestors have a recall of any class.
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?
Philips Radiology Smart Assistant is intended to provide patient positioning feedback using validated 2D X-Ray systems.
Philips Radiology Smart Assistant is a software which informs Healthcare Professionals regarding patient positioning quality in accordance with clinical guidelines. Philips Radiology Smart Assistant is not intended for diagnostic purposes. It is not intended to be used as the basis for repeating an image.
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/K212186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212186: Philips Radiology Smart Assistant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212186
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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