Cleared Traditional

K800592 - SUN SCENE TAN BOOTH (FDA 510(k) Clearance)

K800592 · Sun Scene International, Inc. · Radiology device
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Jun 1980
Decision
79d
Days
-
Risk

K800592 is an FDA 510(k) clearance for the SUN SCENE TAN BOOTH.

Submitted by Sun Scene International, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 4, 1980 after a review of 79 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 Sun Scene International, Inc. devices

Submission Details

510(k) Number K800592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1980
Decision Date June 04, 1980
Days to Decision 79 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 107d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -