Cleared Traditional

K963941 - THE PHARAOH COMPENSATING FILTER

K963941 is an FDA 510(k) clearance for THE PHARAOH COMPENSATING FILTER, manufactured by Octostop, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K963941 · Octostop, Inc. · Radiology device
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Nov 1996
Decision
57d
Days
Class 2
Risk

K963941 is an FDA 510(k) clearance for the THE PHARAOH COMPENSATING FILTER. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Octostop, Inc. (Montreal, Qc., CA). The FDA issued a Cleared decision on November 27, 1996 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Octostop, Inc. devices

FDA 510(k) Submission Details - K963941

510(k) Number K963941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1996
Decision Date November 27, 1996
Days to Decision 57 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
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 215
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K963941.
AMBER DU
K973219 · Oldelft Corp. of America · Oct 1997
PIVOTING COMPENSATING FILTERS FOR THE HEAD
K972766 · Octostop, Inc. · Aug 1997
X-RAY ASSIST BAR
K972000 · Ralph Lindel, D.C. · Jul 1997
KODAK DIGITAL SCIENCE REMOTE CASSETTE
K962896 · Eastman Kodak Company · Sep 1996
UNIVERSIX 120
K954196 · Philips Medical Systems (Cleveland), Inc. · Oct 1995
SOLARIX FV
K953832 · GE Medical Systems · Sep 1995