510(k) · Cleared
ClearedXRpad2 4343 HWC-M Flat Panel Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varex Imaging Corporation · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jul 3, 2018 as substantially equivalent to K161966 (Perkinelmer, Inc., 2016) after a 22-day review. Its family tree reaches back 9 generations to 1998.
- Decided
- Jul 3, 2018
- Review
- 22 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K981556 (1998). 16 ancestors in all, the oldest K862120 (1986). No later device cites it as a predicate yet.
- Root · 9 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 5 generations between
- 3 generations backK122495 Perkinelmer XRD 1622 AP3 Med Flat Panel DetectorPerkinelmer, Inc. · 2012
- 2 generations backK140551 Perkinelmer, Xrpad 4336 Med Flat Panel DetectorPerkinelmer, Inc. · 2014
- 1 generation backK161966 PerkinElmer XRpad2 4336 HWC-M Flat Panel DetectorPerkinelmer, Inc. · 2016
- This deviceK181526 XRpad2 4343 HWC-M Flat Panel DetectorVarex Imaging Corporation · 2018
Show all 9 generations
- Root · 9 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 8 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 7 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 6 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 5 generations backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 4 generations backK063283 Definium 5000 X-Ray SystemSedecal., Sa. · 2006 · Recalled
- 3 generations backK122495 Perkinelmer XRD 1622 AP3 Med Flat Panel DetectorPerkinelmer, Inc. · 2012
- 2 generations backK140551 Perkinelmer, Xrpad 4336 Med Flat Panel DetectorPerkinelmer, Inc. · 2014
- 1 generation backK161966 PerkinElmer XRpad2 4336 HWC-M Flat Panel DetectorPerkinelmer, Inc. · 2016
- This deviceK181526 XRpad2 4343 HWC-M Flat Panel DetectorVarex Imaging Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −8 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −7 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −6 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −5 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −4 | K063283 | Definium 5000 X-Ray System | Sedecal., Sa. | 2006 | 3 |
| −3 | K122495 | Perkinelmer XRD 1622 AP3 Med Flat Panel Detector | Perkinelmer, Inc. | 2012 | — |
| −2 | K140551 | Perkinelmer, Xrpad 4336 Med Flat Panel Detector | Perkinelmer, Inc. | 2014 | — |
| −1 | K161966 | PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector | Perkinelmer, Inc. | 2016 | — |
| 0 (this device) | K181526 | XRpad2 4343 HWC-M Flat Panel Detector | Varex Imaging Corporation | 2018 | — |
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 |
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 |
|---|---|---|---|
| * | K161966 | PerkinElmer XRpad2 4336 HWC-M Flat Panel DetectorSummary page 4…m Classification Regulation: 21 CFR 892.1680 Predicate Device: XRpad 4336 HWC-M Flat Panel Detector 510(k) Clearance: K161966; September 8, 2016 Product Code: MQB Classification Name: Solid state X-ray imager… | 2016 |
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 20 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 16 ancestors have a recall of any class.
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. 2018, 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 XRpad2 4343 HWC-M, 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/K181526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181526: XRpad2 4343 HWC-M 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/K181526
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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