Cleared Traditional

LaVid FMTS DIAGNOSTIC X-RAY SYSTEM (K180663) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180663 · Livermoretech, Inc. · Radiology device
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May 2018
Decision
65d
Days
Class 2
Risk

K180663 is an FDA 510(k) clearance for the LaVid FMTS DIAGNOSTIC X-RAY SYSTEM. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Livermoretech, Inc. (Plano, US). The FDA issued a Cleared decision on May 18, 2018 after a review of 65 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Livermoretech, Inc. devices

Submission Details

510(k) Number K180663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2018
Decision Date May 18, 2018
Days to Decision 65 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 107d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPR System, X-ray, Stationary
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

Mtechgroup
Dave Kim

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 - KPR System, X-ray, Stationary

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