Skip to content

Supria True64 Whole-Body X-Ray CT System

by Hitachi Healthcare Americas Corporation

510(k) K183291

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK183291 Date1 Feb 2019ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1750-2022 FDA Class II initiated 12 Jul 2022
    • Ongoing Z-1749-2022 FDA Class II initiated 12 Jul 2022

    Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JAK
FDA applicant
Hitachi Healthcare Americas
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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Supria True64 Whole-Body X-Ray CT System is a computed tomography scanner designed for whole-body, head, and vascular imaging. As a Whole-Body X-Ray CT System (per FDA nomenclature), it generates cross-sectional images of internal structures using X-rays, enabling detailed visualization for diagnostic purposes across all patient ages. Its 64-slice configuration supports high-resolution imaging with enhanced spatial and temporal resolution, facilitating comprehensive assessments of anatomy and pathology. The device integrates advanced imaging algorithms to optimize scan quality and reduce radiation exposure where clinically appropriate.

This system is supplied as a standalone, non-sterile medical device intended for use in radiology departments, hospitals, and outpatient imaging centers. It is FDA-cleared under 510(k) K183291, classified under product code JAK (Radiology: Computed Tomography, X-Ray), and requires installation by trained personnel. The device is not single-use; it is designed for reusable operation with manufacturer-specified maintenance protocols to ensure consistent performance and safety. No specific MRI safety classification is stated, and storage conditions align with standard CT scanner requirements, including protection from extreme temperatures and physical damage.

Other devices from Hitachi Healthcare Americas Corporation

See all devices from Hitachi Healthcare Americas Corporation →