Cleared Traditional

K946114 - SENSORI-MOTOR RATING SCALE

K946114 is an FDA 510(k) clearance for SENSORI-MOTOR RATING SCALE, manufactured by Cmed. The device is a Class 1 Radiology device with product code IXY cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K946114 · Cmed · Radiology device
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Apr 1995
Decision
134d
Days
Class 1
Risk

K946114 is an FDA 510(k) clearance for the SENSORI-MOTOR RATING SCALE. Classified as Holder, Radiographic Cassette, Wall-mounted (product code IXY), Class I - General Controls.

Submitted by Cmed (Irvine, US). The FDA issued a Cleared decision on April 28, 1995 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1880 - 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 Cmed devices

FDA 510(k) Submission Details - K946114

510(k) Number K946114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1994
Decision Date April 28, 1995
Days to Decision 134 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
27d slower than avg
Panel avg: 107d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

IXY Device Classification - Class 1, General Controls

Product Code IXY Holder, Radiographic Cassette, Wall-mounted
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1880
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IXY Holder, Radiographic Cassette, Wall-mounted

All 7
Devices cleared under the same product code (IXY) and FDA review panel - the closest regulatory comparables to K946114.
VRS 3 WALL STAND
K953336 · Philips Medical Systems (Cleveland), Inc. · Aug 1995
UNIVERSIX 190
K953402 · Philips Medical Systems (Cleveland), Inc. · Aug 1995
WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT
K925934 · Continental X-Ray Corp. · Mar 1993
BASICAM S COUNTER BALANCE CAMERA
K860454 · Siemens Gammasonics, Inc. · Feb 1986
DYNAMIC CARDIAC PHANTOM 74-347
K853756 · Victoreen, Inc. · Oct 1985
MULTI-SIZE CASSETTE HOLDER
K850125 · Philips Medical Systems (Cleveland), Inc. · Mar 1985