510(k) · Cleared
ClearedARiX RAD Radiographic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. · KPR System, X-Ray, Stationary
Cleared on Nov 26, 2018 as substantially equivalent to K090279 (Sedecal., Sa., 2009) after a 112-day review. Its family tree reaches back 6 generations to 1998. 1 later device descends from it.
- Decided
- Nov 26, 2018
- Review
- 112 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K981556 (1998). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 5 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 4 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 3 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 2 generations backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 1 generation backK090279 Sedecal, Millennium PlusSedecal., Sa. · 2009
- This deviceK182134 ARiX RAD Radiographic SystemCompania Mexicana DE Radiologia Cgr, S.A. DE C.V. · 2018
- Descendant · cites it directly · 0 of its ownK193637 MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE…Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. · 2020
Most influential descendants
Showing 1 of 1 · See all- K193637MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic SystemCompania Mexicana DE Radiologia Cgr, S.A. DE C.V. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −5 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −4 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −3 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −2 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −1 | K090279 | Sedecal, Millennium Plus | Sedecal., Sa. | 2009 | — |
| 0 (this device) | K182134 | ARiX RAD Radiographic System | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | 2018 | — |
| +1 | K193637 | MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic… | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | 2020 | — |
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 |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K090279 | Sedecal, Millennium PlusSummary page 4…, System, X-Ray, Stationary Class: Class 2 Classification Panel: Radiology 5.5 Legally Marketed Predicate Device Sedecal Millennium Plus (K090279); Manufacturer: Sedecal S.A. 5.6 Indication for Use The ARiX RAD system is a radiographic system used for producing X-ra… | 2009 |
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 |
|---|---|---|---|
| K193637 | MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System | 2020 | 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 20 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K193637 (Compania Mexicana DE Radiologia Cgr, S.A. DE C.V., 2020) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K090279.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 ARiX RAD system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is design to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the ARiX RAD radiographic system. The acquisition system…
Read the full statement (138 words)
The ARiX RAD system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is design to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the ARiX RAD radiographic system. The acquisition system comes as a separate system.
The ARiX RAD system is not intended for use in mammography, fluoroscopy or angiography.
The ARiX RAD system is intended for adults and pediatric patients. The pediatric population is as follows:
• Child (3–12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
• Adolescent (12–21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182134: ARiX RAD Radiographic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182134
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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