Cleared Traditional

MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC (K031866) - FDA 510(k) Clearance

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

K031866 · Med-Tec,Inc. · Radiology device
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Aug 2003
Decision
59d
Days
Class 2
Risk

K031866 is an FDA 510(k) clearance for the MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC. Classified as Couch, Radiation Therapy, Powered (product code JAI), Class II - Special Controls.

Submitted by Med-Tec,Inc. (Orange City, US). The FDA issued a Cleared decision on August 14, 2003 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5770 - 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 Med-Tec,Inc. devices

Submission Details

510(k) Number K031866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2003
Decision Date August 14, 2003
Days to Decision 59 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 107d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAI Couch, Radiation Therapy, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5770
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 - JAI Couch, Radiation Therapy, Powered

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