Cleared Traditional

K934574 - MODEL MPFT-01, GENESIS

K934574 is an FDA 510(k) clearance for MODEL MPFT-01, manufactured by International Medical Designs, Inc.. The device is a Class 2 Radiology device with product code IXR cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K934574 · International Medical Designs, Inc. · Radiology device
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Mar 1994
Decision
169d
Days
Class 2
Risk

K934574 is an FDA 510(k) clearance for the MODEL MPFT-01, GENESIS. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by International Medical Designs, Inc. (Deltona, US). The FDA issued a Cleared decision on March 4, 1994 after a review of 169 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all International Medical Designs, Inc. devices

FDA 510(k) Submission Details - K934574

510(k) Number K934574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1993
Decision Date March 04, 1994
Days to Decision 169 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
62d slower than avg
Panel avg: 107d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXR Device Classification - Class 2, Special Controls

Product Code IXR Table, Radiographic, Tilting
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 - IXR Table, Radiographic, Tilting

All 49
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K934574.
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