Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways— 510(k) K143294

Name: FDA 510(k) clearance K143294
Creator: U.S. Food and Drug Administration
Published: 2015-05-15

Substantially Equivalent

Toshibamedical Systems Corporation

FDA 510(k) clearance K143294 for Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways, Substantially Equivalent on 2015-05-15. Applicant: Toshibamedical Systems Corporation. Device class: 2.

Clearance details

Applicant: Toshibamedical Systems Corporation
Product code: Code JAK
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2014-11-17
Decision date: 2015-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Otawara-Shi, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code JAK

view all

K253836 — FCT iStream Phase 22026-09-04
K253450 — BodyTom Elite (NL4000)2026-07-28
K253770 — CardIQ Suite2026-07-21
K253560 — Enhanced Boundary for PCCT2026-06-24
K253026 — Respiratory Gating for Scanners (2.1)2026-06-04

More clearances from Toshibamedical Systems Corporation

view all

K173962 — Viamo c100 TUS-VC100 Diagnostic Ultrasound System2018-04-20
K173468 — Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.02018-02-23
K173088 — Vitrea Software Toshiba Package VSTP-001A2018-01-31
K173382 — Vantage Galan 3T, V4.62018-01-26
K173090 — Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.42018-01-11

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.