Cleared Traditional

K837181 - EMINEX LS-8 SYSTEM (FDA 510(k) Clearance)

K837181 · Elscint, Inc. · Radiology device
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Apr 1983
Decision
44d
Days
-
Risk

K837181 is an FDA 510(k) clearance for the EMINEX LS-8 SYSTEM.

Submitted by Elscint, Inc. (Hackensack, US). The FDA issued a Cleared decision on April 1, 1983 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel. 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 Elscint, Inc. devices

Submission Details

510(k) Number K837181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1983
Decision Date April 01, 1983
Days to Decision 44 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 107d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -