510(k) · Cleared
ClearedRadiographic X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orich Medical Equipment (Tianjin Co., Ltd. · KPR System, X-Ray, Stationary
Cleared on Apr 17, 2012 as substantially equivalent to K052541 (Avant Medical Systems, 2005) after a 104-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Apr 17, 2012
- Review
- 104 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001201 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK001201 Multix Compact K and Multix L Radiographic X-Ray SystemsSiemens Medical Solutions USA, Inc. · 2000
- 1 generation backK052541 Model HF-50R Computer Controlled X-Ray SystemAvant Medical Systems · 2005
- This deviceK120034 Radiographic X-Ray SystemOrich Medical Equipment (Tianjin Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK152813 FS-500DDR Medical Radiographic X-Ray SystemOrich Medical Equipment (Tianjin) Co., Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K152813FS-500DDR Medical Radiographic X-Ray SystemOrich Medical Equipment (Tianjin) Co., Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001201 | Multix Compact K and Multix L Radiographic X-Ray Systems | Siemens Medical Solutions USA, Inc. | 2000 | — |
| −1 | K052541 | Model HF-50R Computer Controlled X-Ray System | Avant Medical Systems | 2005 | — |
| 0 (this device) | K120034 | Radiographic X-Ray System | Orich Medical Equipment (Tianjin Co., Ltd. | 2012 | — |
| +1 | K152813 | FS-500DDR Medical Radiographic X-Ray System | Orich Medical Equipment (Tianjin) Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K052541 | Model HF-50R Computer Controlled X-Ray SystemSummary page 1…lassification: Classification: 21 CFR 892.1680; Class 11 Product Code: KPR 4. Predicate Devices: Model HF-5OR Computer K052541 AVANT Medical Systems -Controlled X-Ray Syse 5. Description of Device The DF-21 I H Radiographic X… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152813 | FS-500DDR Medical Radiographic X-Ray System | 2016 | 0 |
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 3 companies; a new generation was cleared every 6.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K152813 (Orich Medical Equipment (Tianjin) Co., Ltd., 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
DF-21 I1H Radiographic X-Ray system is designed to be. used by a qualified/trained doctor or technician on adult and pediatric patients for taking diagnostic images of the skull, spinal colum, chest, abdomen, extremities and other body parts. 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/K120034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120034: Radiographic 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/K120034
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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