510(k) · Cleared
ClearedDigital X-Ray Imaging System, Model DRC-1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
VATECH Co., Ltd. · KPR System, X-Ray, Stationary
Cleared on Jul 21, 2010 as substantially equivalent to K090238 (Sedecal., Sa., 2009) after a 310-day review. Its family tree reaches back 6 generations to 1998. 18 later devices descend from it.
- Decided
- Jul 21, 2010
- Review
- 310 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K981556 (1998). 12 ancestors in all. 18 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 5 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 4 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 3 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 2 generations backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 1 generation backK090238 Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa. · 2009
- This deviceK092830 Digital X-Ray Imaging System, Model DRC-1000VATECH Co., Ltd. · 2010
- Descendant · cites it directly · 17 of its ownK091090 Digital Flat Panel X-Ray Detector, Model Xmaru 1717E-Woo Technology · 2010
- Descendant · 2 generations on · 13 of its ownK142475 EVS 4343DRTECH Corporation · 2015
- Descendant · 3 generations on · 7 of its ownK162555 Evs 4343, Evs 4343GDRTECH Corporation · 2016
- Descendant · 4 generations on · 6 of its ownK192400 Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AGDRTECH Corporation · 2019
- Descendant · 3 generations on · 4 of its ownK151942 EVS 3643DRTECH Corporation · 2015
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K091090Digital Flat Panel X-Ray Detector, Model Xmaru 1717E-Woo Technology · 2010 · cites it directly17descendants
- K142475EVS 4343DRTECH Corporation · 2015 · 2 generations on13descendants
- K162555Evs 4343, Evs 4343GDRTECH Corporation · 2016 · 3 generations on7descendants
- K192400Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AGDRTECH Corporation · 2019 · 4 generations on6descendants
- K151942EVS 3643DRTECH Corporation · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −5 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −4 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −3 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −2 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −1 | K090238 | Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems | Sedecal., Sa. | 2009 | — |
| 0 (this device) | K092830 | Digital X-Ray Imaging System, Model DRC-1000 | VATECH Co., Ltd. | 2010 | — |
| +1 | K091090 | Digital Flat Panel X-Ray Detector, Model Xmaru 1717 | E-Woo Technology | 2010 | — |
| +2 | K142475 | EVS 4343 | DRTECH Corporation | 2015 | — |
| +3 | K162555 | Evs 4343, Evs 4343G | DRTECH Corporation | 2016 | — |
| +4 | K192400 | Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AG | DRTECH Corporation | 2019 | — |
| +3 | K151942 | EVS 3643 | DRTECH Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 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 |
|---|---|---|---|
| * | K090238 | Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSummary page 1…odel Name :Sedecal X-Plus LP Plus Digital Classification Name : SYSTEM, X -RA Y, STA TION AR Y 51 0(k) Number :K090238 (Decision Date - Feb. 27. 2009) 4. Classifications Names & Citations 2I CFR 892.1680, KPR, System, X-ray, Stationary, C… | 2009 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091090 | Digital Flat Panel X-Ray Detector, Model Xmaru 1717 | 2010 | 17 |
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 12 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K091090 (E-Woo Technology, 2010) has gone furthest, with 17 descendants of its own.
- 4 other devices also cite its predicate K090238.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
Digital X-ray Imaging System, DRC-1000, is intended for by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, extremities, and other body parts. Not to be used for fluoroscopy, angiography, or screening mammography. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092830 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092830: Digital X-Ray Imaging System, Model DRC-1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092830
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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