# K152294: FDR Visionary Suite

- Pathway: 510(k) (Traditional)
- Applicant: Shimadzu Corporation
- Decided: Jul 15, 2016 after 337 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K862120 (1986). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093427: FDR Acselerate System, DR-ID 200 Flat Panel Detector, Fujifilm Medical System U.S.A., Inc. (2010) Summary page 4.
- K121499: Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray System, Fujifilm Medical System U.S.A., Inc. (2012) Summary page 4.
- K101686: FDR Image Stitching Option, Fujifilm Medical System U.S.A., Inc. (2010) Summary page 4.
- K122454: Fujifilm Dual Energy Subtraction (Des) Software Option, Fujifilm Medical System U.S.A., Inc. (2012) Summary page 4.

## Most influential descendants
- K233719: FDR Visionary Suite (2024), 0 descendants of its own

## Recalls of this device
- Jan 9, 2026 · Class II · Z-1299-2026: 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 sup
- Sep 15, 2025 · Class II · Z-0044-2026: 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 whi
- Apr 11, 2024 · Class II · Z-1898-2024: 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: 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 fla
- May 23, 2017 · Class II · Z-2655-2017: Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.

## Indications for use
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.

Source page: https://510kreport.com/device/K152294
Methodology: https://510kreport.com/methodology