Cleared Traditional

K904103 - SEP 90 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K904103 · Elema-Schonander, Inc. · Radiology device
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Nov 1990
Decision
75d
Days
Class 2
Risk

K904103 is an FDA 510(k) clearance for the SEP 90. Classified as Programmer, Changer, Film/cassette, Radiographic (product code IZP), Class II - Special Controls.

Submitted by Elema-Schonander, Inc. (Schaumburg, US). The FDA issued a Cleared decision on November 20, 1990 after a review of 75 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

Submission Details

510(k) Number K904103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1990
Decision Date November 20, 1990
Days to Decision 75 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 107d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.