Cleared Traditional

K828619 - OHMICRON MAMMOGRAPHY X-RAY SYSTEM MODEL OMC 4520M (FDA 510(k) Clearance)

K828619 · Ohmic , Ltd. · Radiology device
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Jan 1983
Decision
41d
Days
-
Risk

K828619 is an FDA 510(k) clearance for the OHMICRON MAMMOGRAPHY X-RAY SYSTEM MODEL OMC 4520M.

Submitted by Ohmic , Ltd. (Walker, US). The FDA issued a Cleared decision on January 3, 1983 after a review of 41 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 Ohmic , Ltd. devices

Submission Details

510(k) Number K828619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1982
Decision Date January 03, 1983
Days to Decision 41 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 107d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -