Cleared Traditional

K230918 - MasterX 800 Series

K230918 is an FDA 510(k) clearance for MasterX 800 Series, manufactured by Medicatech USA. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K230918 · Medicatech USA · Radiology device
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Sep 2023
Decision
151d
Days
Class 2
Risk

K230918 is an FDA 510(k) clearance for the MasterX 800 Series. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Medicatech USA (Irvine, US). The FDA issued a Cleared decision on September 1, 2023 after a review of 151 days - an extended review cycle.

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 Medicatech USA devices

FDA 510(k) Submission Details - K230918

510(k) Number K230918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2023
Decision Date September 01, 2023
Days to Decision 151 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
44d slower than avg
Panel avg: 107d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
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 Consultant

Kamm & Associates
Daniel Kamm

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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