Cleared Traditional

K034054 - PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100

K034054 is an FDA 510(k) clearance for PRO SERIES COUCH SOFTWARE, manufactured by Med-Tec,Inc.. The device is a Class 2 Radiology device with product code JAI cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K034054 · Med-Tec,Inc. · Radiology device
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Feb 2004
Decision
52d
Days
Class 2
Risk

K034054 is an FDA 510(k) clearance for the PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100. 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 February 20, 2004 after a review of 52 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

FDA 510(k) Submission Details - K034054

510(k) Number K034054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2003
Decision Date February 20, 2004
Days to Decision 52 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
55d faster than avg
Panel avg: 107d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAI Device Classification - Class 2, Special Controls

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

All 14
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