Cleared Traditional

K952701 - MED-TRON SPECT IMAGING TABLE

K952701 is an FDA 510(k) clearance for MED-TRON SPECT IMAGING TABLE, manufactured by Med-Tron Products, Inc.. The device is a Class 2 Radiology device with product code IZZ cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K952701 · Med-Tron Products, Inc. · Radiology device
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Jul 1995
Decision
23d
Days
Class 2
Risk

K952701 is an FDA 510(k) clearance for the MED-TRON SPECT IMAGING TABLE. Classified as Table, Radiographic, Non-tilting, Powered (product code IZZ), Class II - Special Controls.

Submitted by Med-Tron Products, Inc. (Port Jefferson Sta., US). The FDA issued a Cleared decision on July 6, 1995 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - 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-Tron Products, Inc. devices

FDA 510(k) Submission Details - K952701

510(k) Number K952701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1995
Decision Date July 06, 1995
Days to Decision 23 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
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZZ Device Classification - Class 2, Special Controls

Product Code IZZ Table, Radiographic, Non-tilting, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
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 - IZZ Table, Radiographic, Non-tilting, Powered

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