Cleared Traditional

K943343 - FIELD ABUTMENT WEDGE

K943343 is an FDA 510(k) clearance for FIELD ABUTMENT WEDGE, manufactured by Medtec, Inc.. The device is a Class 2 Radiology device with product code IXI cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K943343 · Medtec, Inc. · Radiology device
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Dec 1994
Decision
164d
Days
Class 2
Risk

K943343 is an FDA 510(k) clearance for the FIELD ABUTMENT WEDGE. Classified as Block, Beam-shaping, Radiation Therapy (product code IXI), Class II - Special Controls.

Submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on December 23, 1994 after a review of 164 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5710 - 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 Medtec, Inc. devices

FDA 510(k) Submission Details - K943343

510(k) Number K943343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1994
Decision Date December 23, 1994
Days to Decision 164 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
57d slower than avg
Panel avg: 107d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXI Device Classification - Class 2, Special Controls

Product Code IXI Block, Beam-shaping, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5710
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 - IXI Block, Beam-shaping, Radiation Therapy

All 31
Devices cleared under the same product code (IXI) and FDA review panel - the closest regulatory comparables to K943343.
SIEMENS VIRTURAL WEDGE
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VARIAN MULTILEAF COLLIMATOR
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