510(k) · Cleared
Recalled · Class II · 2026FDR 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 Jul 15, 2016 as substantially equivalent to K093427 (Fujifilm Medical System U.S.A., Inc., 2010) and 3 other predicates after a 337-day review. Its family tree reaches back 6 generations to 1986. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Jul 15, 2016
- Review
- 337 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 5
- Predicates
- 4
Its longest line of descent runs back 6 generations to K862120 (1986). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 5 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 4 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 3 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 2 generations backK051967 Revolution XR/D Digital Radiographic Imaging System with TomosynthesisGE Healthcare · 2005 · Recalled
- 1 generation backK121499 Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray…Fujifilm Medical System U.S.A., Inc. · 2012
- This deviceK152294 FDR Visionary SuiteShimadzu Corporation · 2016
- Descendant · cites it directly · 0 of its ownK233719 FDR Visionary SuiteShimadzu Corporation · 2024
Most influential descendants
Showing 1 of 1 · See all- K233719FDR Visionary SuiteShimadzu Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −5 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −4 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −3 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −2 | K051967 | Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis | GE Healthcare | 2005 | 9 |
| −1 | K121499 | Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray System | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| 0 (this device) | K152294 | FDR Visionary Suite | Shimadzu Corporation | 2016 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (4)
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 |
|---|---|---|---|
| * | K093427 | FDR Acselerate System, DR-ID 200 Flat Panel DetectorSummary page 4…ay system (21 CFR§892.1680) Classification Panel : Radiology Regulatory Class : Class II Product Code : KPR 6) Predicate Device Primary K093427 FDR ACSELERATE SYSTEM, DR-ID 200 FUJIFILM FLAT PANEL DETECTOR… | 2010 |
| * | K121499 | Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray SystemSummary page 4…K093427 FDR ACSELERATE SYSTEM, DR-ID 200 FUJIFILM FLAT PANEL DETECTOR CORPORATION Secondary K121499 FUJIFILM TOMOSYNTHESIS OPTION FUJIFILM FOR FDR ACSELERATE STATIONARY… | 2012 |
| * | K101686 | FDR Image Stitching OptionSummary page 4…OPTION FUJIFILM FOR FDR ACSELERATE STATIONARY CORPORATION X-RAY SYSTEM Tertiary K101686 FDR IMAGE STITCHING OPTION FUJIFILM CORPORATION Quaternary… | 2010 |
| * | K122454 | Fujifilm Dual Energy Subtraction (Des) Software OptionSummary page 4…X-RAY SYSTEM Tertiary K101686 FDR IMAGE STITCHING OPTION FUJIFILM CORPORATION Quaternary K122454 FUJIFILM DUAL ENERGY SUBTRACTION FUJIFILM (DES) SOFTWARE OPTION CORPORATION No refere… | 2012 |
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 |
|---|---|---|---|
| K233719 | FDR Visionary Suite | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 9, 2026 | Class II | Z-1299-2026 | Process control | It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the… |
| Sep 15, 2025 | Class II | Z-0044-2026 | Device Design | It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front… |
| Apr 11, 2024 | Class II | Z-1898-2024 | Component design/selection | Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury |
| Jun 15, 2017 | Class II | Z-0232-2018 | Device Design | A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR Visionary Suite. The X-ray tube assembly in these devices is mounted to a tube mounting flange, which is part of the tube holding… |
| May 23, 2017 | Class II | Z-2655-2017 | Device Design | Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 4.0 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K233719 (Shimadzu Corporation, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K093427.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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/K152294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152294: 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/K152294
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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