510(k) · Cleared
ClearedPhilips Pixium 4343RC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Dmc GmbH · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Oct 7, 2013 as substantially equivalent to K982795 (Philips Medical Systems, Inc., 1998) and 1 other predicate after a 137-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Oct 7, 2013
- Review
- 137 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K931071 (1994). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK931071 Philips ThoravisionPhilips Medical Systems, Inc. · 1994 · Recalled
- 2 generations backK982795 Philips Bucky VisionPhilips Medical Systems, Inc. · 1998 · Recalled
- 1 generation backK090625 Wireless Portable Detector FD-W17Philips Medical Systems North America Co. · 2009 · Recalled
- This deviceK131483 Philips Pixium 4343RCPhilips Medical Systems Dmc GmbH · 2013
- Descendant · cites it directly · 0 of its ownK170113 pixium 4343RCEPhilips Medical Systems Dmc GmbH · 2017
Most influential descendants
Showing 1 of 1 · See all- K170113pixium 4343RCEPhilips Medical Systems Dmc GmbH · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931071 | Philips Thoravision | Philips Medical Systems, Inc. | 1994 | 1 |
| −2 | K982795 | Philips Bucky Vision | Philips Medical Systems, Inc. | 1998 | 17 |
| −1 | K090625 | Wireless Portable Detector FD-W17 | Philips Medical Systems North America Co. | 2009 | 28 |
| 0 (this device) | K131483 | Philips Pixium 4343RC | Philips Medical Systems Dmc GmbH | 2013 | — |
| +1 | K170113 | pixium 4343RCE | Philips Medical Systems Dmc GmbH | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K982795 | Philips Bucky VisionSummary page 1…Classification Panel: 90 - Radiology, Class 11 Equivalent legally marketed devices: Philips BuckyVision. K982795 (introducing the Trixell Pixiun, 4600 Stationary Solid State X-ray Imager). The lBuckyVision system… | 1998 |
| * | K090625 | Wireless Portable Detector FD-W17Summary page 1…m is also marketed under the commercial name of IDigimal Din gnost. Philips Wireless Portable Detector FD-W 17. K090625 -I of7 - Device Description: The Pixiurn 4343RC is a Solid State X… | 2009 |
| † | K123005 | Ddrversa Motion | 2012 |
| † | K063781 | Philips XD-S Direct Radiography Workstation/Package | 2007 |
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 |
|---|---|---|---|
| K170113 | pixium 4343RCE | 2017 | 0 |
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 19 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K170113 (Philips Medical Systems Dmc GmbH, 2017) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K982795.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
As a part of a radiographic system, the Pixium 4343RC is intended to acquire digital radiographic images. The Pixium 4343RC is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131483 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131483: Philips Pixium 4343RC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131483
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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