510(k) · Cleared
ClearedPerkinelmer, Xrpad 4336 Med Flat Panel Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perkinelmer, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Aug 1, 2014 as substantially equivalent to K122495 (Perkinelmer, Inc., 2012) after a 150-day review. Its family tree reaches back 7 generations to 1998. 12 later devices descend from it.
- Decided
- Aug 1, 2014
- Review
- 150 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K981556 (1998). 14 ancestors in all, the oldest K862120 (1986). 12 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 6 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 5 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 4 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 3 generations backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 2 generations backK063283 Definium 5000 X-Ray SystemSedecal., Sa. · 2006 · Recalled
- 1 generation backK122495 Perkinelmer XRD 1622 AP3 Med Flat Panel DetectorPerkinelmer, Inc. · 2012
- This deviceK140551 Perkinelmer, Xrpad 4336 Med Flat Panel DetectorPerkinelmer, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK142698 PerkinElmer, XRpad 4343 F MED Flat Panel DetectorPerkinelmer, Inc. · 2014
- Descendant · cites it directly · 6 of its ownK162529 DigiX FDXAllengers Medical Systems Limited · 2017
- Descendant · 2 generations on · 5 of its ownK192541 DigiX FDXAllengers Medical Systems Limited · 2019
- Descendant · 3 generations on · 4 of its ownK223060 DigiX FDXAllengers Medical Systems Limited · 2022
- Descendant · 4 generations on · 3 of its ownK230985 Planmeca VisoPlanmeca Oy · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K142698PerkinElmer, XRpad 4343 F MED Flat Panel DetectorPerkinelmer, Inc. · 2014 · cites it directly7descendants
- K162529DigiX FDXAllengers Medical Systems Limited · 2017 · cites it directly6descendants
- K192541DigiX FDXAllengers Medical Systems Limited · 2019 · 2 generations on5descendants
- K223060DigiX FDXAllengers Medical Systems Limited · 2022 · 3 generations on4descendants
- K230985Planmeca VisoPlanmeca Oy · 2023 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −6 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −5 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −4 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −3 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −2 | K063283 | Definium 5000 X-Ray System | Sedecal., Sa. | 2006 | 3 |
| −1 | K122495 | Perkinelmer XRD 1622 AP3 Med Flat Panel Detector | Perkinelmer, Inc. | 2012 | — |
| 0 (this device) | K140551 | Perkinelmer, Xrpad 4336 Med Flat Panel Detector | Perkinelmer, Inc. | 2014 | — |
| +1 | K142698 | PerkinElmer, XRpad 4343 F MED Flat Panel Detector | Perkinelmer, Inc. | 2014 | — |
| +1 | K162529 | DigiX FDX | Allengers Medical Systems Limited | 2017 | — |
| +2 | K192541 | DigiX FDX | Allengers Medical Systems Limited | 2019 | — |
| +3 | K223060 | DigiX FDX | Allengers Medical Systems Limited | 2022 | — |
| +4 | K230985 | Planmeca Viso | Planmeca Oy | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K122495 | Perkinelmer XRD 1622 AP3 Med Flat Panel DetectorSummary page 4…0 Radiology Product Code: (MQB) Predicate device: XRD 1622 AP3 MED X-ray system (Flat Panel Detector in system) [K122495] Device Description: The XRpad 4336 MED is a flat panel X-ray detector consisting of an amorphous silicon panel with a directl… | 2012 |
What descends from it? (12)
See all 125 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)
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 16 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K142698 (Perkinelmer, Inc., 2014) has gone furthest, with 7 descendants of its own.
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. 2014, 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?
The XRpad 4336 MED, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.
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/K140551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140551: Perkinelmer, Xrpad 4336 Med Flat Panel Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140551
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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