Cleared Traditional

K827543 - MAXICAMERA MODEL 200A (FDA 510(k) Clearance)

K827543 · General Electric Co. · Radiology device
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Jul 1982
Decision
45d
Days
-
Risk

K827543 is an FDA 510(k) clearance for the MAXICAMERA MODEL 200A.

Submitted by General Electric Co. (Des Plaines, US). The FDA issued a Cleared decision on July 9, 1982 after a review of 45 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 General Electric Co. devices

Submission Details

510(k) Number K827543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1982
Decision Date July 09, 1982
Days to Decision 45 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 107d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -