Cleared Traditional

K941719 - 360 DEG. ROTATING 1/2 BEAM BLOCK

K941719 is an FDA 510(k) clearance for 360 DEG. ROTATING 1/2 BEAM BLOCK, 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 102-day FDA review.

K941719 · Medtec, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K941719

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.

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 K941719.
SIEMENS MULTILEAF COLLIMATOR
K953894 · Siemens Medical Solutions USA, Inc. · Nov 1995
MULTILEAF INTENSITY MODULATING COLLIMATOR
K940412 · Nomos Corp. · Feb 1995
FIELD ABUTMENT WEDGE
K943343 · Medtec, Inc. · Dec 1994
PHILIPS MULTILEAF COLLIMATOR (MLC)
K904124 · Philips Medical Systems, Inc. · Jan 1991
VARIAN MULTILEAF COLLIMATOR
K893464 · Varian Assoc., Inc. · Aug 1989