AmCAD-UT— 510(k) K203555

Substantially Equivalent

Amcad Biomed Corporation

FDA 510(k) clearance K203555 for AmCAD-UT, Substantially Equivalent on 2021-09-08. Applicant: Amcad Biomed Corporation. Device class: 2.

Clearance details

Applicant: Amcad Biomed Corporation
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2020-12-07
Decision date: 2021-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Amcad Biomed Corporation

K180867 — AmCAD-UO2018-12-28
K180006 — AmCAD-UT Detection 2.22018-08-31
K162574 — AmCAD-US2017-05-30
K170069 — AmCAD-UV2017-04-26

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