510(k) · Cleared
ClearedSkanrad 400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skanray Technologies Limited · KPR System, X-Ray, Stationary
Cleared on Apr 1, 2022 as substantially equivalent to K173517 (Shimadzu Corporation, 2018) after a 37-day review. Its family tree reaches back 12 generations to 1998.
- Decided
- Apr 1, 2022
- Review
- 37 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K981556 (1998). 32 ancestors in all, the oldest K862120 (1986). No later device cites it as a predicate yet.
- Root · 12 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 8 generations between
- 3 generations backK131106 Digital Radiography Cxdi-701C Wireless, Digital Radiography…Canon, Inc. · 2013
- 2 generations backK170332 Digital Radiography Cxdi-710C Wireless, Digital Radiography…Canon, Inc. · 2017
- 1 generation backK173517 RADspeed fitShimadzu Corporation · 2018
- This deviceK220518 Skanrad 400Skanray Technologies Limited · 2022
Show all 12 generations
- Root · 12 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 11 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 10 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 9 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 8 generations backK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
- 7 generations backK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
- 6 generations backK102012 Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · Recalled
- 5 generations backK103591 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
- 4 generations backK112309 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
- 3 generations backK131106 Digital Radiography Cxdi-701C Wireless, Digital Radiography…Canon, Inc. · 2013
- 2 generations backK170332 Digital Radiography Cxdi-710C Wireless, Digital Radiography…Canon, Inc. · 2017
- 1 generation backK173517 RADspeed fitShimadzu Corporation · 2018
- This deviceK220518 Skanrad 400Skanray Technologies Limited · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −11 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −10 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −9 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −8 | K060433 | Digital Radiography Cxdi-50C | Canon, Inc. | 2006 | — |
| −7 | K091545 | Digital Radiography Cxdi-60C | Canon, Inc. | 2009 | — |
| −6 | K102012 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2010 | 1 |
| −5 | K103591 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2011 | — |
| −4 | K112309 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2011 | — |
| −3 | K131106 | Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG… | Canon, Inc. | 2013 | — |
| −2 | K170332 | Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C Wireless | Canon, Inc. | 2017 | — |
| −1 | K173517 | RADspeed fit | Shimadzu Corporation | 2018 | — |
| 0 (this device) | K220518 | Skanrad 400 | Skanray Technologies Limited | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K173517 | RADspeed fitSummary page 4…component parts, and accessories Review Panel: Radiology Device Class: Class II Product Code: KPR Predicate Device: RADspeed Fit (K173517) Regulation number: 21 CFR 892.1680 Regulation name: Stationary X-ray system… | 2018 |
| † | K161459 | Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) | 2016 |
| † | K172951 | Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) | 2017 |
| † | K130883 | Sedecal Digital Radiographic Upgrade Model Sdru-T | 2013 |
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 24 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 32 ancestors have a recall of any class.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 SKANRAD 400 is intended for use in generating X-Rays & radiographic images of human anatomy including skull, spinal column, chest, abdomen, extremities and other body parts in all general-purpose X-ray diagnostic procedures. The device is intended for use in paediatric and adult. It may be used in radiology departments, paediatrics, orthopaedics and clinics. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine…
Read the full statement (122 words)
The SKANRAD 400 is intended for use in generating X-Rays & radiographic images of human anatomy including skull, spinal column, chest, abdomen, extremities and other body parts in all general-purpose X-ray diagnostic procedures. The device is intended for use in paediatric and adult. It may be used in radiology departments, paediatrics, orthopaedics and clinics. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. Device is designed to be used with conventional film/screen or computed radiography (CR) cassettes / DR system.
The system has been designed for indoor usage. It is intended for qualified medical personnel or operators who have been trained in the use of X-Ray equipment. SKANRAD 400 is not intended for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220518 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220518: Skanrad 400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220518
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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