510(k) · Cleared
ClearedClearvision DR 2000 Digital Radiography X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jpi Healthcare Co, Ltd. · KPR System, X-Ray, Stationary
Cleared on May 16, 2011 as substantially equivalent to K083640 (Choong Wae Medical Corp., 2009) and 2 other predicates after a 325-day review. Its family tree reaches back 5 generations to 1986.
- Decided
- May 16, 2011
- Review
- 325 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K862120 (1986). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 4 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 3 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 2 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 1 generation backK083640 Digital X-Ray Imaging System, Model: CXD-DR80DChoong Wae Medical Corp. · 2009
- This deviceK101779 Clearvision DR 2000 Digital Radiography X-Ray SystemJpi Healthcare Co, Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −4 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −3 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −2 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −1 | K083640 | Digital X-Ray Imaging System, Model: CXD-DR80D | Choong Wae Medical Corp. | 2009 | — |
| 0 (this device) | 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 |
| 1997 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 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? (3)
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 |
|---|---|---|---|
| * | K083640 | Digital X-Ray Imaging System, Model: CXD-DR80DSummary page 1…ar Vision DR 2000 3. Predicate Device Manufacturer: Choongwae Medical Corporation Device: CXD-DR80D 510(k) Number: K083640 (Decision Date Jul 29, 2009) Manufacturer: Vieworks Co., Ltd Device: QXR 9 5 10(k) Nu… | 2009 |
| * | K073056 | Digital Radiography System, Model: QXR-9Summary page 2…assembly mounted on a U-Arm, along with a generator, generator control, and a detector, operating software. The detector which is used proposed device is QXR9 (K073056) and QXRI 6 (K080553) of Vieworks Co., Ltd. These detectors are cleared by FDA 5 10(k). 6. Indication for use The Clear V… | 2007 |
| * | K080553 | Digital Radiography System, Model QXR-16Summary page 1…0(k) Number: K(073056 (Decision Date Nov 13, 2007) Manufacturer: Vieworks Co., Ltd Device: QXR 16 5 10(k) Number: K080553 (Decision Date Apr 16, 2008) 4. Product Classification Names and Citations Regulatory Number: 21 CFR 892.1680… | 2008 |
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 25 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K083640.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Clear Vision DR 2000 product is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column,, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
The Clear Vision DR 2000 system is intended to be used in medical clinics and hospitals for emergency, orthopedic, chiropractic, and other medical purposes. This device is not indicated for use in mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101779: Clearvision DR 2000 Digital Radiography X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101779
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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