Cleared Traditional

K842911 - PUCK U & UD CUTFILM CHANGERS

K842911 is an FDA 510(k) clearance for PUCK U & UD CUTFILM CHANGERS, 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 29-day FDA review.

K842911 · Elema-Schonander, Inc. · Radiology device
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Aug 1984
Decision
29d
Days
Class 2
Risk

K842911 is an FDA 510(k) clearance for the PUCK U & UD CUTFILM CHANGERS. Classified as Changer, Radiographic Film/cassette (product code KPX), Class II - Special Controls.

Submitted by Elema-Schonander, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 21, 1984 after a review of 29 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 - K842911

510(k) Number K842911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1984
Decision Date August 21, 1984
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
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 K842911.
UNIVERSAL STAND FOR FILM CHANGER
K862575 · Canon USA, Inc. · Jul 1986
UNIVERSAL STAND FOR FILM CHANGER
K853928 · Canon USA, Inc. · Oct 1985
CANON X-RAY FILM CHANGER CFC-U1
K851067 · Canon USA, Inc. · May 1985
CP-625 SEE-THRU FILM CHANGER
K811967 · Philips Medical Systems (Cleveland), Inc. · Aug 1981
ULTIMAT L4 X L4, LIEBEL-FLARSHEIM
K770836 · Mallinckrodt Group, Inc. · May 1977
X-RAY FILM, CONVEY OR SYSTEM
K760279 · Mallinckrodt Group, Inc. · Aug 1976