Cleared Traditional

K940412 - MULTILEAF INTENSITY MODULATING COLLIMATOR

K940412 is an FDA 510(k) clearance for MULTILEAF INTENSITY MODULATING COLLIMATOR, manufactured by Nomos Corp.. The device is a Class 2 Radiology device with product code IXI cleared through the Traditional 510(k) pathway after a 384-day FDA review.

K940412 · Nomos Corp. · Radiology device
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Optimized for regulatory review, auditing and printing
Feb 1995
Decision
384d
Days
Class 2
Risk

K940412 is an FDA 510(k) clearance for the MULTILEAF INTENSITY MODULATING COLLIMATOR. Classified as Block, Beam-shaping, Radiation Therapy (product code IXI), Class II - Special Controls.

Submitted by Nomos Corp. (Sewickley, US). The FDA issued a Cleared decision on February 15, 1995 after a review of 384 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Nomos Corp. devices

FDA 510(k) Submission Details - K940412

510(k) Number K940412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1994
Decision Date February 15, 1995
Days to Decision 384 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
277d slower than avg
Panel avg: 107d · This submission: 384d
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 15
Devices cleared under the same product code (IXI) and FDA review panel - the closest regulatory comparables to K940412.
SIEMENS BEAM SHAPER
K961902 · Siemens Medical Solutions USA, Inc. · Aug 1996
SIEMENS VIRTURAL WEDGE
K954248 · Siemens Medical Solutions USA, Inc. · Jan 1996
SIEMENS MULTILEAF COLLIMATOR
K953894 · Siemens Medical Solutions USA, Inc. · Nov 1995
FIELD ABUTMENT WEDGE
K943343 · Medtec, Inc. · Dec 1994
360 DEG. ROTATING 1/2 BEAM BLOCK
K941719 · Medtec, Inc. · Jul 1994
PHILIPS MULTILEAF COLLIMATOR (MLC)
K904124 · Philips Medical Systems, Inc. · Jan 1991