510(k) · Cleared
ClearedRADspeed fit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shimadzu Corporation · KPR System, X-Ray, Stationary
Cleared on Mar 30, 2018 as substantially equivalent to K152244 (Shimadzu Corporation, 2016) and 1 other predicate after a 136-day review. Its family tree reaches back 11 generations to 1998. 1 later device descends from it.
- Decided
- Mar 30, 2018
- Review
- 136 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K981556 (1998). 31 ancestors in all, the oldest K862120 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 7 generations between
- 3 generations backK112309 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
- 2 generations backK131106 Digital Radiography Cxdi-701C Wireless, Digital Radiography…Canon, Inc. · 2013
- 1 generation backK170332 Digital Radiography Cxdi-710C Wireless, Digital Radiography…Canon, Inc. · 2017
- This deviceK173517 RADspeed fitShimadzu Corporation · 2018
- Descendant · cites it directly · 0 of its ownK220518 Skanrad 400Skanray Technologies Limited · 2022
Show all 11 generations
- Root · 11 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 10 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 9 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 8 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 7 generations backK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
- 6 generations backK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
- 5 generations backK102012 Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · Recalled
- 4 generations backK103591 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
- 3 generations backK112309 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
- 2 generations backK131106 Digital Radiography Cxdi-701C Wireless, Digital Radiography…Canon, Inc. · 2013
- 1 generation backK170332 Digital Radiography Cxdi-710C Wireless, Digital Radiography…Canon, Inc. · 2017
- This deviceK173517 RADspeed fitShimadzu Corporation · 2018
Most influential descendants
Showing 1 of 1 · See all- K220518Skanrad 400Skanray Technologies Limited · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −10 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −9 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −8 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −7 | K060433 | Digital Radiography Cxdi-50C | Canon, Inc. | 2006 | — |
| −6 | K091545 | Digital Radiography Cxdi-60C | Canon, Inc. | 2009 | — |
| −5 | K102012 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2010 | 1 |
| −4 | K103591 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2011 | — |
| −3 | K112309 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2011 | — |
| −2 | K131106 | Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG… | Canon, Inc. | 2013 | — |
| −1 | K170332 | Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C Wireless | Canon, Inc. | 2017 | — |
| 0 (this device) | K173517 | RADspeed fit | Shimadzu Corporation | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K152244 | RADspeed ProSummary page 4…: Class II Product Code : KPR 6) Predicate Device SHIMADZU Primary K152244 KPR RADspeed Pro CORPORATON… | 2016 |
| * | K170332 | Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C WirelessSummary page 4…CORPORATON Digital Radiography CXDI-710C Wireless Secondary K170332 MQB Canon, Inc. Digital Radiography… | 2017 |
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 |
|---|---|---|---|
| K220518 | Skanrad 400 | 2022 | 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 1.2 years on median.
- 6 of the 31 ancestors have a recall of any class.
- Of its descendants, K220518 (Skanray Technologies Limited, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K152244.
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 RADspeed fit is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The RADspeed fit enables radiographic exposure of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The RADspeed fit uses…
Read the full statement (149 words)
The RADspeed fit is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The RADspeed fit enables radiographic exposure of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The RADspeed fit uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The device is not intended for mammographic applications or tomographic techniques. The indications for use remain the same as those for the predicate, except for the removal of tomographic technique.
WARNING: United States Federal Law restricts this device to sale by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173517: RADspeed fit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173517
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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