TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)— 510(k) K230136

Name: FDA 510(k) clearance K230136
Creator: U.S. Food and Drug Administration
Published: 2023-04-24

Substantially Equivalent

Compai Healthcare (Suzhou) Co.,Ltd

FDA 510(k) clearance K230136 for TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US), Substantially Equivalent on 2023-04-24. Applicant: Compai Healthcare (Suzhou) Co.,Ltd. Device class: 2.

Clearance details

Applicant: Compai Healthcare (Suzhou) Co.,Ltd
Product code: Code MWP
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2023-01-18
Decision date: 2023-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code MWP

view all

K230140 — TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)2023-04-24
K213691 — Solas OR2021-12-22
K210955 — Kubtec Mozart Supra (XPERT 84) Radiography System2021-09-20
K210956 — Kubtec Mozart (XPERT42)2021-08-31
K210957 — Kubec Xpert 80 Radiography System2021-08-31

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