510(k) · Cleared
ClearedEvs 4343W / Evs 4343WG / Evs 4343WP / Evs 3643W / Evs 3643WG / Evs 3643WP
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 Nov 22, 2019 as substantially equivalent to K162552 (DRTECH Corporation, 2016) after a 24-day review. Its family tree reaches back 11 generations to 1998. 1 later device descends from it.
- Decided
- Nov 22, 2019
- Review
- 24 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K981556 (1998). 21 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 7 generations between
- 3 generations backK142475 EVS 4343DRTECH Corporation · 2015
- 2 generations backK151942 EVS 3643DRTECH Corporation · 2015
- 1 generation backK162552 Evs 3643, Evs 3643GDRTECH Corporation · 2016
- This deviceK193017 Evs 4343W / Evs 4343WG / Evs 4343WP / Evs 3643W / Evs 3643WG / Evs…DRTECH Corporation · 2019
- Descendant · cites it directly · 0 of its ownK243443 Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd…DRTECH Corporation · 2025
Show all 11 generations
- Root · 11 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 10 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 9 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 8 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 7 generations backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 6 generations backK090238 Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa. · 2009
- 5 generations backK092830 Digital X-Ray Imaging System, Model DRC-1000VATECH Co., Ltd. · 2010
- 4 generations backK091090 Digital Flat Panel X-Ray Detector, Model Xmaru 1717E-Woo Technology · 2010
- 3 generations backK142475 EVS 4343DRTECH Corporation · 2015
- 2 generations backK151942 EVS 3643DRTECH Corporation · 2015
- 1 generation backK162552 Evs 3643, Evs 3643GDRTECH Corporation · 2016
- This deviceK193017 Evs 4343W / Evs 4343WG / Evs 4343WP / Evs 3643W / Evs 3643WG / Evs…DRTECH Corporation · 2019
Most influential descendants
Showing 1 of 1 · See all- K243443Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N…DRTECH Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −10 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −9 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −8 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −7 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −6 | K090238 | Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems | Sedecal., Sa. | 2009 | — |
| −5 | K092830 | Digital X-Ray Imaging System, Model DRC-1000 | VATECH Co., Ltd. | 2010 | — |
| −4 | K091090 | Digital Flat Panel X-Ray Detector, Model Xmaru 1717 | E-Woo Technology | 2010 | — |
| −3 | K142475 | EVS 4343 | DRTECH Corporation | 2015 | — |
| −2 | K151942 | EVS 3643 | DRTECH Corporation | 2015 | — |
| −1 | K162552 | Evs 3643, Evs 3643G | DRTECH Corporation | 2016 | — |
| 0 (this device) | K193017 | Evs 4343W / Evs 4343WG / Evs 4343WP / Evs 3643W / Evs 3643WG / Evs 3643WP | DRTECH Corporation | 2019 | — |
| +1 | K243443 | Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1… | DRTECH Corporation | 2025 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K162552 | Evs 3643, Evs 3643GSummary page 5…roduct Code: MQB Device Class: II 4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)] 510(k) Number: K162552 Applicant: DRTECH Corporation Trade Name: EVS 3643 / EVS 3643G Classificat… | 2016 |
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 |
|---|---|---|---|
| K243443 | Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N… | 2025 | 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 21 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K243443 (DRTECH Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K162552.
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. 2019, 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 EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP Digital X-ray detector is
indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This
device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This
device is not intended for mammography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193017 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193017: Evs 4343W / Evs 4343WG / Evs 4343WP / Evs 3643W / Evs 3643WG / Evs 3643WP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193017
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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