510(k) · Cleared
Recalled · 2004Philips Thoravision
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · KPR System, X-Ray, Stationary
Cleared on Sep 15, 1994 after a 562-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 143 later devices descend from it. It has been recalled once.
- Decided
- Sep 15, 1994
- Review
- 562 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 1
- Predicates
- 0
143 later devices descend from it, 2 citing it directly.
- This deviceK931071 Philips ThoravisionPhilips Medical Systems, Inc. · 1994
- Descendant · cites it directly · 141 of its ownK982795 Philips Bucky VisionPhilips Medical Systems, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 103 of its ownK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- Descendant · 2 generations on · 78 of its ownK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- Descendant · 2 generations on · 41 of its ownK090625 Wireless Portable Detector FD-W17Philips Medical Systems North America Co. · 2009 · Recalled
- Descendant · 3 generations on · 34 of its ownK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
Showing 5 of 143 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 143 · See all- K982795Philips Bucky VisionPhilips Medical Systems, Inc. · 1998 · cites it directly141descendants
- K992794Stingray DR, Model 1Infimed, Inc. · 1999 · 2 generations on103descendants
- K024147Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003 · 2 generations on78descendants
- K090625Wireless Portable Detector FD-W17Philips Medical Systems North America Co. · 2009 · 2 generations on41descendants
- K092669DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · 3 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931071 | Philips Thoravision | Philips Medical Systems, Inc. | 1994 | — |
| +1 | K982795 | Philips Bucky Vision | Philips Medical Systems, Inc. | 1998 | 17 |
| +2 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| +2 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| +2 | K090625 | Wireless Portable Detector FD-W17 | Philips Medical Systems North America Co. | 2009 | 28 |
| +3 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 6 | 0 |
| 2010 | 6 | 0 |
| 2011 | 10 | 0 |
| 2012 | 5 | 0 |
| 2013 | 11 | 0 |
| 2014 | 12 | 0 |
| 2015 | 5 | 0 |
| 2016 | 10 | 0 |
| 2017 | 12 | 0 |
| 2018 | 5 | 0 |
| 2019 | 9 | 0 |
| 2020 | 7 | 0 |
| 2021 | 12 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (143)
See all 1432 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 |
|---|---|---|---|---|
| Dec 1, 2004 | Not classified | Z-0369-05 | Other | X-Ray system may fall downward and could possibly hit the patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K982795 (Philips Medical Systems, Inc., 1998) has gone furthest, with 141 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.
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 | — |
https://510kreport.com/device/K931071 · printed Nov 4, 2026
Cite this page
510(k) Report. “K931071: Philips Thoravision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K931071
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026