510(k) · Cleared
ClearedEXPD 4343S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DRTECH Corporation · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Feb 13, 2024 as substantially equivalent to K193031 (DRTECH Corporation, 2019) after a 215-day review. Its family tree reaches back 12 generations to 1998.
- Decided
- Feb 13, 2024
- Review
- 215 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K981556 (1998). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 8 generations between
- 3 generations backK162555 Evs 4343, Evs 4343GDRTECH Corporation · 2016
- 2 generations backK192400 Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AGDRTECH Corporation · 2019
- 1 generation backK193031 Expd 4343P, Expd 3643PDRTECH Corporation · 2019
- This deviceK232082 EXPD 4343SDRTECH Corporation · 2024
Show all 12 generations
- Root · 12 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 11 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 10 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 9 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 8 generations backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 7 generations backK090238 Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa. · 2009
- 6 generations backK092830 Digital X-Ray Imaging System, Model DRC-1000VATECH Co., Ltd. · 2010
- 5 generations backK091090 Digital Flat Panel X-Ray Detector, Model Xmaru 1717E-Woo Technology · 2010
- 4 generations backK142475 EVS 4343DRTECH Corporation · 2015
- 3 generations backK162555 Evs 4343, Evs 4343GDRTECH Corporation · 2016
- 2 generations backK192400 Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AGDRTECH Corporation · 2019
- 1 generation backK193031 Expd 4343P, Expd 3643PDRTECH Corporation · 2019
- This deviceK232082 EXPD 4343SDRTECH Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −11 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −10 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −9 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −8 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −7 | K090238 | Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems | Sedecal., Sa. | 2009 | — |
| −6 | K092830 | Digital X-Ray Imaging System, Model DRC-1000 | VATECH Co., Ltd. | 2010 | — |
| −5 | K091090 | Digital Flat Panel X-Ray Detector, Model Xmaru 1717 | E-Woo Technology | 2010 | — |
| −4 | K142475 | EVS 4343 | DRTECH Corporation | 2015 | — |
| −3 | K162555 | Evs 4343, Evs 4343G | DRTECH Corporation | 2016 | — |
| −2 | K192400 | Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AG | DRTECH Corporation | 2019 | — |
| −1 | K193031 | Expd 4343P, Expd 3643P | DRTECH Corporation | 2019 | — |
| 0 (this device) | K232082 | EXPD 4343S | DRTECH Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K193031 | Expd 4343P, Expd 3643PSummary page 4…on of Predicate Device(s) [21 CFR 807.92(a) (3)] The identified predicate device(s) within this submission are as follows: • 510(k) Number: K193031 • Manufacturer: DRTECH Corporation • Common Name: Digital Flat Panel X-ray Detec… | 2019 |
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 26 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 22 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. 2024, 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 EXPD 4343S Digital X-ray detector is indicated for use in generating radiographic images of
human anatomy. This device is intended to replace film or screen based radiographic systems in
all general purpose diagnostic procedures on general populations.
This device is not intended for mammography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232082 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232082: EXPD 4343S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232082
Report an extraction error
Are you the manufacturer?
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