Cleared Traditional

K941719 - 360 DEG. ROTATING 1/2 BEAM BLOCK

K941719 is the FDA 510(k) clearance for 360 DEG. ROTATING 1/2 BEAM BLOCK by Medtec, Inc.. It is a Class 2 Radiology device (product code IXI) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K941719 · Medtec, Inc. · Radiology device
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Jul 1994
Decision
102d
Days
Class 2
Risk

K941719 is an FDA 510(k) clearance for the 360 DEG. ROTATING 1/2 BEAM BLOCK. 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 July 18, 1994 after a review of 102 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K941719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1994
Decision Date July 18, 1994
Days to Decision 102 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
5d faster than avg
Panel avg: 107d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 12
Devices cleared under the same product code (IXI) and FDA review panel - the closest regulatory comparables to K941719.
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K943343 · Medtec, Inc. · Dec 1994
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K893464 · Varian Assoc., Inc. · Aug 1989