Cleared Traditional

K837443 - OM-1 DIAPHANOGRAPHY LIGHT TRANSILLUMINATION SYSTEM SOR MAMMOGRAPHY (FDA 510(k) Clearance)

K837443 · Medical Diagnostic Instruments, Inc. · Radiology device
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Jun 1983
Decision
42d
Days
-
Risk

K837443 is an FDA 510(k) clearance for the OM-1 DIAPHANOGRAPHY LIGHT TRANSILLUMINATION SYSTEM SOR MAMMOGRAPHY.

Submitted by Medical Diagnostic Instruments, Inc. (Hamden, US). The FDA issued a Cleared decision on June 10, 1983 after a review of 42 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 Medical Diagnostic Instruments, Inc. devices

Submission Details

510(k) Number K837443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1983
Decision Date June 10, 1983
Days to Decision 42 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 107d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -