510(k) · Cleared
ClearedEXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DRTECH Corporation · KPR System, X-Ray, Stationary
Cleared on Sep 8, 2026 as substantially equivalent to K242847 (DRTECH Corporation, 2024) after a 225-day review. Its family tree reaches back 11 generations to 1998.
- Decided
- Sep 8, 2026
- Review
- 225 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K981556 (1998). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 7 generations between
- 3 generations backK202572 GXR-Series Diagnostic X-Ray SystemDRGEM Corporation · 2020
- 2 generations backK233530 EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS…DRTECH Corporation · 2024
- 1 generation backK242847 EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS…DRTECH Corporation · 2024
- This deviceK260227 EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS…DRTECH Corporation · 2026
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 backK102408 Digital Diagnostic X-Ray SystemDRGEM Corporation · 2010
- 4 generations backK192364 GXR-Series Diagnostic X-Ray SystemDRGEM Corporation · 2019
- 3 generations backK202572 GXR-Series Diagnostic X-Ray SystemDRGEM Corporation · 2020
- 2 generations backK233530 EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS…DRTECH Corporation · 2024
- 1 generation backK242847 EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS…DRTECH Corporation · 2024
- This deviceK260227 EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS…DRTECH Corporation · 2026
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 | K102408 | Digital Diagnostic X-Ray System | DRGEM Corporation | 2010 | — |
| −4 | K192364 | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | 2019 | — |
| −3 | K202572 | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | 2020 | — |
| −2 | K233530 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS… | DRTECH Corporation | 2024 | — |
| −1 | K242847 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS… | DRTECH Corporation | 2024 | — |
| 0 (this device) | K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS… | DRTECH Corporation | 2026 | — |
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 |
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 |
|---|---|---|---|
| * | K242847 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS…Summary page 6…EXSYS DEXi 510(k) Summary 4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)] • 510(k) Number: K242847 • Applicant: DRTECH Corporation • Trade(Brand) Name: EXSYS DEXi • Device(Model) Name :… | 2024 |
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 28 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 17 ancestors has a recall of any class.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
The EXSYS DEXi is a diagnostic X-ray system intended for use in generating radiographic images of human anatomy for general purpose. The system obtains necessary information of patient’s anatomical structure by an image processing (workstation) after process of examination using radiation exposure with DR. This system is not intended for mammography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260227: EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260227
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026