510(k) · Cleared
ClearedDigital X-Ray Imaging System, Model: CXD-DR80D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Choong Wae Medical Corp. · KPR System, X-Ray, Stationary
Cleared on Jun 29, 2009 as substantially equivalent to K012389 (Ge Medical Systems, Inc., 2001) and 1 other predicate after a 202-day review. Its family tree reaches back 4 generations to 1986. 2 later devices descend from it.
- Decided
- Jun 29, 2009
- Review
- 202 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K862120 (1986). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 3 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 2 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 1 generation backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- This deviceK083640 Digital X-Ray Imaging System, Model: CXD-DR80DChoong Wae Medical Corp. · 2009
- Descendant · cites it directly · 0 of its ownK102327 Clearvision DR 7000FJpi Healthcare Co, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK101779 Clearvision DR 2000 Digital Radiography X-Ray SystemJpi Healthcare Co, Ltd. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −3 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −2 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −1 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| 0 (this device) | K083640 | Digital X-Ray Imaging System, Model: CXD-DR80D | Choong Wae Medical Corp. | 2009 | — |
| +1 | K102327 | Clearvision DR 7000F | Jpi Healthcare Co, Ltd. | 2012 | — |
| +1 | K101779 | Clearvision DR 2000 Digital Radiography X-Ray System | Jpi Healthcare Co, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 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 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? (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 |
|---|---|---|---|
| * | K012389 | Revolution XR/D Digital Radiographic Imaging SystemSummary page 1…dicate Device: Manufacturer · General Electric Company Device · Revolution XR/d 510(k) Number · K012389 (Decision Date - Aug. 10. 2001) Manufacturer · DRTECH Co., Ltd. Device · FLA… | 2001 |
| * | K080064 | Flaatz 750Summary page 1…sion Date - Aug. 10. 2001) Manufacturer · DRTECH Co., Ltd. Device · FLAATZ 750 510(k) Number · k080064 (Decision Date - Jan. 23. 2008) 4. Classifications Names & Citations: 21CFR 872.1680, KPR, System, x-ray, stationary, Cla… | 2008 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 4 companies; a new generation was cleared every 7.9 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K102327 (Jpi Healthcare Co, Ltd., 2012) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K012389.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 CXD-DR80D Digital X-ray Imaging System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.
The CXD-DR80D Digital X-ray Imaging System utilizes the FLAATZ 750 Detector, manufactured by DRTECH Co. (K080064)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083640 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083640: Digital X-Ray Imaging System, Model: CXD-DR80D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083640
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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