Supria Whole-body X-ray CT System
by Hitachi Medical Systems America, Inc.
510(k) K150565
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150565 | Date30 Sep 2015 | 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- Withdrawn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, 19 Sep 2026
The Supria Whole-body X-ray CT System is a 16-slice multi-slice computed tomography system that uses a rotating gantry with slip ring technology, an X-ray tube, and a solid-state detector array to collect data for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. Images can be acquired in axial, helical, or dynamic modes and processed by a high-speed reconstruction subsystem into cross-sectional images.
The system is operated by qualified physicians or technicians in clinical settings. It received FDA 510(k) clearance under K150565 with a traditional review and was found substantially equivalent. The device is supplied as a non-sterile, reusable system for use in healthcare facilities, with no MRI safety information provided in the data.
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Questions
AI-generated answers, 19 Sep 2026
What is the Supria Whole-body X-ray CT System used for?
The Supria Whole-body X-ray CT System is used to acquire head, whole body, and vascular X-ray Computed Tomography images in patients of all ages. It supports axial, helical, and dynamic scanning modes, with data processed by a high-speed reconstruction subsystem into cross-sectional images for clinical interpretation by qualified physicians or technicians.
How is the Supria Whole-body X-ray CT System supplied and is it sterile or reusable?
The system is supplied as a non-sterile, reusable system intended for use in healthcare facilities. It is not provided sterile and is designed for repeated use after appropriate cleaning and maintenance procedures, as no sterility or single-use claims are indicated in the device data.
What regulatory pathway was used for the Supria Whole-body X-ray CT System, and what was the outcome?
The device received FDA 510(k) clearance under submission K150565 through a traditional review process. It was found substantially equivalent to a predicate device, as indicated by the decision code SESE and decision description 'Substantially Equivalent', with no mention of FDA approval, CE marking, or other regulatory statuses beyond the 510(k) clearance.
What type of facility and operators are appropriate for the Supria Whole-body X-ray CT System?
The system is intended for use in clinical settings by qualified physicians or technicians. It is designed for healthcare facilities where trained personnel operate the gantry, X-ray tube, detector array, and reconstruction subsystem to perform CT imaging procedures on patients across all age groups.
Does the Supria Whole-body X-ray CT System include MRI safety information?
No MRI safety information is provided in the device data. The Supria Whole-body X-ray CT System is an X-ray-based computed tomography system, and the documentation does not contain any details regarding its safety or compatibility in magnetic resonance environments.