510(k) · Cleared
ClearedJumong Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sg Healthcare Co, Ltd. · KPR System, X-Ray, Stationary
Cleared on May 8, 2015 as substantially equivalent to K133782 (Sedecal., Sa., 2014) after a 42-day review. Its family tree reaches back 7 generations to 1998. 2 later devices descend from it.
- Decided
- May 8, 2015
- Review
- 42 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K981556 (1998). 11 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 6 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 5 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 4 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 3 generations backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 2 generations backK090279 Sedecal, Millennium PlusSedecal., Sa. · 2009
- 1 generation backK133782 Nova FA DR SystemSedecal., Sa. · 2014 · Recalled
- This deviceK150816 Jumong SeriesSg Healthcare Co, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK230241 Jumong GeneralSg Healthcare Co, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK183541 ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited · 2019
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 |
|---|---|---|---|---|---|
| −7 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −6 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −5 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −4 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −3 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −2 | K090279 | Sedecal, Millennium Plus | Sedecal., Sa. | 2009 | — |
| −1 | K133782 | Nova FA DR System | Sedecal., Sa. | 2014 | 1 |
| 0 (this device) | K150816 | Jumong Series | Sg Healthcare Co, Ltd. | 2015 | — |
| +1 | K230241 | Jumong General | Sg Healthcare Co, Ltd. | 2023 | — |
| +1 | K183541 | ProRad 2FC and ProRad 3NC Stationary Radiographic Systems | Prognosys Medical Systems Private Limited | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K133782 | Nova FA DR SystemSummary page 4…System, Product codes KPR and MQB Common/Usual Name: Diagnositc X-Ray System Device Class: II per regulation 21CFR 892.1680 2. Equivalent legally marketed device: K133782, Sedecal Nova FA DR System, Sedecal SA. 3. Indications for Use The Jumong Series is intended for use by a qualified/trained doct… | 2014 |
| † | K103591 | Digital Radiography | 2011 |
| † | K091436 | Digital Radiography, Model Cxdi-55C | 2009 |
| † | K111682 | Digital Radiography | 2011 |
| † | K122865 | Vivix-S Wireless | 2013 |
| † | K122866 | Vivix-S with Vxvue | 2013 |
| † | K120020 | Vivix-S | 2012 |
| † | K090238 | Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems | 2009 |
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 17 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K230241 (Sg Healthcare Co, Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K133782.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Jumong Series Stationary Radiographic System 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. Not for mammography.
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/K150816 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150816: Jumong Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150816
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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