Cleared Traditional

FOCISCAN ECHOVISOR SYSTEM (K781348) - FDA 510(k) Clearance

K781348 · Metrix Teknika, Inc. · Obstetrics & Gynecology device
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Oct 1978
Decision
57d
Days
-
Risk

K781348 is an FDA 510(k) clearance for the FOCISCAN ECHOVISOR SYSTEM.

Submitted by Metrix Teknika, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 3, 1978 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology 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 Metrix Teknika, Inc. devices

Submission Details

510(k) Number K781348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1978
Decision Date October 03, 1978
Days to Decision 57 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 160d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -