Cleared Traditional

K972766 - PIVOTING COMPENSATING FILTERS FOR THE HEAD

K972766 is an FDA 510(k) clearance for PIVOTING COMPENSATING FILTERS FOR THE HEAD, 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 21-day FDA review.

K972766 · Octostop, Inc. · Radiology device
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Aug 1997
Decision
21d
Days
Class 2
Risk

K972766 is an FDA 510(k) clearance for the PIVOTING COMPENSATING FILTERS FOR THE HEAD. 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 August 14, 1997 after a review of 21 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 - K972766

510(k) Number K972766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1997
Decision Date August 14, 1997
Days to Decision 21 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
86d faster than avg
Panel avg: 107d · This submission: 21d
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 214
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K972766.
DIGITAL ADD ON MULTI SYSTEM
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DIGITAL ADD-ON BUCKY
K970136 · Swissray Teleray AG · Nov 1997
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K973219 · Oldelft Corp. of America · Oct 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