Cleared Traditional

K230140 - TrueView Core 100Pro-US Core Specimen R...

K230140 is an FDA 510(k) clearance for TrueView Core 100Pro-US Core Specimen R..., manufactured by Compai Healthcare (Suzhou) Co.,Ltd. The device is a Class 2 Radiology device with product code MWP cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K230140 · Compai Healthcare (Suzhou) Co.,Ltd · Radiology device
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Apr 2023
Decision
96d
Days
Class 2
Risk

K230140 is an FDA 510(k) clearance for the TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pr.... Classified as Cabinet, X-ray System (product code MWP), Class II - Special Controls.

Submitted by Compai Healthcare (Suzhou) Co.,Ltd (Suzhou, CN). The FDA issued a Cleared decision on April 24, 2023 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Compai Healthcare (Suzhou) Co.,Ltd devices

FDA 510(k) Submission Details - K230140

510(k) Number K230140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2023
Decision Date April 24, 2023
Days to Decision 96 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 107d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWP Device Classification - Class 2, Special Controls

Product Code MWP Cabinet, X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MWP Cabinet, X-ray System

All 15
Devices cleared under the same product code (MWP) and FDA review panel - the closest regulatory comparables to K230140.
TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)
K230136 · Compai Healthcare (Suzhou) Co.,Ltd · Apr 2023
Solas OR
K213691 · Cirdan Imaging, Ltd. · Dec 2021
Kubtec Mozart Supra (XPERT 84) Radiography System
K210955 · Kub Technologies, Inc. · Sep 2021
Kubtec Mozart (XPERT42)
K210956 · Kub Technologies, Inc. · Aug 2021
Kubec Xpert 80 Radiography System
K210957 · Kub Technologies, Inc. · Aug 2021
TrueView 100 Pro
K202713 · Compai Healthcare (Shenzhen) Co.,Ltd · Nov 2020