Cleared Traditional

K903576 - PUCK 90M

K903576 is an FDA 510(k) clearance for PUCK 90M, manufactured by Elema-Schonander, Inc.. The device is a Class 2 Radiology device with product code KPX cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K903576 · Elema-Schonander, Inc. · Radiology device
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Sep 1990
Decision
27d
Days
Class 2
Risk

K903576 is an FDA 510(k) clearance for the PUCK 90M. Classified as Changer, Radiographic Film/cassette (product code KPX), Class II - Special Controls.

Submitted by Elema-Schonander, Inc. (Schaumburg, US). The FDA issued a Cleared decision on September 4, 1990 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1860 - 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 Elema-Schonander, Inc. devices

FDA 510(k) Submission Details - K903576

510(k) Number K903576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1990
Decision Date September 04, 1990
Days to Decision 27 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPX Device Classification - Class 2, Special Controls

Product Code KPX Changer, Radiographic Film/cassette
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1860
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 - KPX Changer, Radiographic Film/cassette

All 13
Devices cleared under the same product code (KPX) and FDA review panel - the closest regulatory comparables to K903576.
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K870048 · Canon USA, Inc. · Jan 1987
UNIVERSAL STAND FOR FILM CHANGER
K862575 · Canon USA, Inc. · Jul 1986
UNIVERSAL STAND FOR FILM CHANGER
K853928 · Canon USA, Inc. · Oct 1985