Cleared Traditional

K837084 - ULTRASOUND EQUIPMENT MODEL SDL-100A (FDA 510(k) Clearance)

K837084 · Elscint, Inc. · Radiology device
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Apr 1983
Decision
93d
Days
-
Risk

K837084 is an FDA 510(k) clearance for the ULTRASOUND EQUIPMENT MODEL SDL-100A.

Submitted by Elscint, Inc. (Hackensack, US). The FDA issued a Cleared decision on April 28, 1983 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Elscint, Inc. devices

Submission Details

510(k) Number K837084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1983
Decision Date April 28, 1983
Days to Decision 93 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 107d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -