510(k) · Cleared
ClearedFDR Visionary Suite
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 28, 2024 as substantially equivalent to K152294 (Shimadzu Corporation, 2016) after a 128-day review. Its family tree reaches back 7 generations to 1986.
- Decided
- Mar 28, 2024
- Review
- 128 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K862120 (1986). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 6 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 5 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 4 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 3 generations backK051967 Revolution XR/D Digital Radiographic Imaging System with TomosynthesisGE Healthcare · 2005 · Recalled
- 2 generations backK121499 Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray…Fujifilm Medical System U.S.A., Inc. · 2012
- 1 generation backK152294 FDR Visionary SuiteShimadzu Corporation · 2016 · Recalled
- This deviceK233719 FDR Visionary SuiteShimadzu Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −6 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −5 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −4 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −3 | K051967 | Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis | GE Healthcare | 2005 | 9 |
| −2 | K121499 | Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray System | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| −1 | K152294 | FDR Visionary Suite | Shimadzu Corporation | 2016 | 5 |
| 0 (this device) | K233719 | FDR Visionary Suite | Shimadzu Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K152294 | FDR Visionary SuiteSummary page 4…Regulation Number: 21CFR892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: II Product Code: KPR, MQB 2. Equivalent legally marketed device: K152294 Trade/Device Name: FDR Visionary Suite Manufacturer: Shimadzu. Regulation Number: 21CFR892.1680 Regulation Name: Stat… | 2016 |
| † | K142003 | FDR D-Evo II Flat Panel Detector System | 2014 |
| † | K192932 | FDR D-EVO III flat panel detector system | 2019 |
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 38 years and passes through 6 companies; a new generation was cleared every 4.0 years on median.
- 5 of the 14 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. 2024, 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 FDR Visionary Suite 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 FDR Visionary Suite enables radiographic or tomographic exposures 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…
Read the full statement (163 words)
The FDR Visionary Suite 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 FDR Visionary Suite enables radiographic or tomographic
exposures 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 FDR Visionary Suite 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 Tomosynthesis option is intended to generate tomographic images
of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane
of the body by reconstruction of tomographic acquisition. The device is intended to be used in
hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained
professionals. The device is not intended for mammographic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233719: FDR Visionary Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233719
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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