Cleared Traditional

K842903 - SEP PROGRAMMER FOR PUCK U & UD FILMCHANG

K842903 is an FDA 510(k) clearance for SEP PROGRAMMER FOR PUCK U & UD FILMCHANG, manufactured by Elema-Schonander, Inc.. The device is a Class 2 Radiology device with product code IZP cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K842903 · Elema-Schonander, Inc. · Radiology device
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Aug 1984
Decision
28d
Days
Class 2
Risk

K842903 is an FDA 510(k) clearance for the SEP PROGRAMMER FOR PUCK U & UD FILMCHANG. Classified as Programmer, Changer, Film/cassette, Radiographic (product code IZP), Class II - Special Controls.

Submitted by Elema-Schonander, Inc. (Walker, US). The FDA issued a Cleared decision on August 21, 1984 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1870 - 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 - K842903

510(k) Number K842903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1984
Decision Date August 21, 1984
Days to Decision 28 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZP Device Classification - Class 2, Special Controls

Product Code IZP Programmer, Changer, Film/cassette, Radiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1870
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 - IZP Programmer, Changer, Film/cassette, Radiographic

Devices cleared under the same product code (IZP) and FDA review panel - the closest regulatory comparables to K842903.
PHILIPS ANGIOPRO
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