Cleared Traditional

K940145 - COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K940145 · Huestis Machine Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
386d
Days
Class 2
Risk

K940145 is an FDA 510(k) clearance for the COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Huestis Machine Corp. (Bristol, US). The FDA issued a Cleared decision on January 24, 1995 after a review of 386 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 Huestis Machine Corp. devices

Submission Details

510(k) Number K940145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1994
Decision Date January 24, 1995
Days to Decision 386 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
279d slower than avg
Panel avg: 107d · This submission: 386d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - IYE Accelerator, Linear, Medical

All 730
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K940145.
VERIQA RT EPID 3D
K252258 · Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla · Apr 2026
ClearCheck (RADCC V2.7)
K253962 · Radformation, Inc. · Apr 2026
AlignRT Plus (8.0)
K253012 · Vision Rt, Ltd. · Mar 2026
Halcyon, Ethos Radiotherapy System (5.0)
K252977 · Varian Medical Systems, Inc. · Jan 2026
EMLA (Elekta Evo)
K252188 · Elekta Solutions AB · Jan 2026
ExacTrac Dynamic (2.0.2)
K254010 · Brainlab SE · Jan 2026