Aquilion One Vision
by Toshibamedical Systems Corporation
510(k) K133497
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK133497 | Date10 Feb 2014 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JAK
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Aquilion One Vision is a computed tomography (CT) scanner designed for high-resolution, multi-slice imaging. It integrates advanced detector technology and reconstruction algorithms to deliver detailed cross-sectional images of the body, supporting diagnostic evaluations in radiology. The device is classified under the product code JAK, reflecting its role in computed tomography imaging systems. Its design emphasizes precision and efficiency for clinical workflows.
This CT scanner is supplied as a reusable medical device, intended for use in radiology departments within hospital or clinical settings. It operates under standard electrical and environmental conditions, with no specific sterility requirements beyond routine cleaning and maintenance protocols. The device adheres to FDA clearance (510K) and is regulated under the Radiology Advisory Committee (RA) for traditional clearance pathways. No MRI safety classifications or single-use specifications are noted in its documentation.
Other devices from Toshiba Medical Systems
Questions
AI-generated answers, 20 Sep 2026
What types of medical facilities would typically use the Aquilion One Vision CT scanner, and why is it suited for those environments?
The Aquilion One Vision is designed for radiology departments in hospital or clinical settings where high-resolution imaging is critical. Its advanced detector technology and reconstruction algorithms enable detailed cross-sectional imaging, making it ideal for diagnostic evaluations across various specialties. The device’s precision and efficiency support busy clinical workflows, ensuring consistent performance in environments requiring reliable CT imaging.
Is the Aquilion One Vision a single-use or reusable device, and what maintenance is required to keep it operational?
The Aquilion One Vision is a reusable medical device, meaning it is built for repeated use in clinical settings. Since it is not sterile by design, routine cleaning and maintenance are required to ensure proper functionality and hygiene. The manufacturer provides guidelines for upkeep, but no special sterility protocols are specified beyond standard radiology department practices.
How is the Aquilion One Vision regulated, and which advisory committee oversees its clearance process?
The Aquilion One Vision is regulated under the FDA’s 510(k) clearance pathway, classified under product code JAK for computed tomography imaging systems. Its clearance was determined by the Radiology (RA) Advisory Committee, which evaluates devices for substantial equivalence to predicate technologies. The device follows traditional clearance procedures, meaning it was compared to an existing, legally marketed CT scanner.
What distinguishes the Aquilion One Vision from other CT scanners in terms of its imaging capabilities?
The Aquilion One Vision is distinguished by its integration of advanced detector technology and reconstruction algorithms, which enhance image resolution and detail. This design allows for high-quality cross-sectional imaging, supporting precise diagnostic evaluations in radiology. Its focus on precision and efficiency aligns with modern clinical needs for faster, more accurate imaging.