Cleared Traditional

K828543 - UNKNOWN (FDA 510(k) Clearance)

K828543 · General Electric Co. · Radiology device
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Jan 1985
Decision
775d
Days
-
Risk

K828543 is an FDA 510(k) clearance for the UNKNOWN.

Submitted by General Electric Co. (Schenectady, US). The FDA issued a Cleared decision on January 1, 1985 after a review of 775 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

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Submission Details

510(k) Number K828543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1982
Decision Date January 01, 1985
Days to Decision 775 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
668d slower than avg
Panel avg: 107d · This submission: 775d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -