Cleared Abbreviated

K201488 - Rover

K201488 is the FDA 510(k) clearance for Rover by Micro-X , Ltd.. It is a Class 2 Radiology device (product code IZL) cleared through the Abbreviated 510(k) pathway after a 43-day FDA review.

K201488 · Micro-X , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2020
Decision
43d
Days
Class 2
Risk

K201488 is an FDA 510(k) clearance for the Rover. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Micro-X , Ltd. (Tonsley (Clovelly Park), AU). The FDA issued a Cleared decision on July 17, 2020 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Micro-X , Ltd. devices

Submission Details

510(k) Number K201488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2020
Decision Date July 17, 2020
Days to Decision 43 days
Submission Type Abbreviated
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
64d faster than avg
Panel avg: 107d · This submission: 43d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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.

Regulatory Peers - IZL System, X-ray, Mobile

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