510(k) · Cleared
ClearedEvs 4343, Evs 4343G
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 Dec 21, 2016 as substantially equivalent to K142475 (DRTECH Corporation, 2015) and 1 other predicate after a 99-day review. Its family tree reaches back 9 generations to 1998. 7 later devices descend from it.
- Decided
- Dec 21, 2016
- Review
- 99 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K981556 (1998). 19 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 5 generations between
- 3 generations backK092830 Digital X-Ray Imaging System, Model DRC-1000VATECH Co., Ltd. · 2010
- 2 generations backK091090 Digital Flat Panel X-Ray Detector, Model Xmaru 1717E-Woo Technology · 2010
- 1 generation backK142475 EVS 4343DRTECH Corporation · 2015
- This deviceK162555 Evs 4343, Evs 4343GDRTECH Corporation · 2016
- Descendant · cites it directly · 6 of its ownK192400 Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AGDRTECH Corporation · 2019
- Descendant · 2 generations on · 2 of its ownK223124 Expd 86P, Expd 86PG, Expd 129P, Expd 129PGDRTECH Corporation · 2022
- Descendant · 2 generations on · 1 of its ownK193031 Expd 4343P, Expd 3643PDRTECH Corporation · 2019
- Descendant · 3 generations on · 0 of its ownK242770 Expd 114; Expd 114G; Expd 114P; Expd 114PGDRTECH Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK232082 EXPD 4343SDRTECH Corporation · 2024
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 backK090238 Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa. · 2009
- 3 generations backK092830 Digital X-Ray Imaging System, Model DRC-1000VATECH Co., Ltd. · 2010
- 2 generations backK091090 Digital Flat Panel X-Ray Detector, Model Xmaru 1717E-Woo Technology · 2010
- 1 generation backK142475 EVS 4343DRTECH Corporation · 2015
- This deviceK162555 Evs 4343, Evs 4343GDRTECH Corporation · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K192400Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AGDRTECH Corporation · 2019 · cites it directly6descendants
- K223124Expd 86P, Expd 86PG, Expd 129P, Expd 129PGDRTECH Corporation · 2022 · 2 generations on2descendants
- K193031Expd 4343P, Expd 3643PDRTECH Corporation · 2019 · 2 generations on1descendant
- K242770Expd 114; Expd 114G; Expd 114P; Expd 114PGDRTECH Corporation · 2025 · 3 generations on0descendants
- K232082EXPD 4343SDRTECH Corporation · 2024 · 3 generations on0descendants
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 | K090238 | Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems | Sedecal., Sa. | 2009 | — |
| −3 | K092830 | Digital X-Ray Imaging System, Model DRC-1000 | VATECH Co., Ltd. | 2010 | — |
| −2 | K091090 | Digital Flat Panel X-Ray Detector, Model Xmaru 1717 | E-Woo Technology | 2010 | — |
| −1 | K142475 | EVS 4343 | DRTECH Corporation | 2015 | — |
| 0 (this device) | K162555 | Evs 4343, Evs 4343G | DRTECH Corporation | 2016 | — |
| +1 | K192400 | Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AG | DRTECH Corporation | 2019 | — |
| +2 | K223124 | Expd 86P, Expd 86PG, Expd 129P, Expd 129PG | DRTECH Corporation | 2022 | — |
| +2 | K193031 | Expd 4343P, Expd 3643P | DRTECH Corporation | 2019 | — |
| +3 | K242770 | Expd 114; Expd 114G; Expd 114P; Expd 114PG | DRTECH Corporation | 2025 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K142475 | EVS 4343Summary page 4…ion of Predicate Device(s) [21 CFR 807.92(a) (3)] Parameter Predicate Device • 510(k) Number: K142475 K150766 • Applicant: DRTECH Corporation Carestream Health, In… | 2015 |
| * | K150766 | Carestream DRX-1 SystemSummary page 4…807.92(a) (3)] Parameter Predicate Device • 510(k) Number: K142475 K150766 • Applicant: DRTECH Corporation Carestream Health, Inc. • Trade Name:… | 2015 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192400 | Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AG | 2019 | 6 |
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 18 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 19 ancestors have a recall of any class.
- Of its descendants, K192400 (DRTECH Corporation, 2019) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K142475.
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. 2016, 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 4343 and EVS 4343G 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162555: Evs 4343, Evs 4343G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162555
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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