Cleared Traditional

K801163 - SUNBURST, SUN SYSTEMS OR BC2 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K801163 · Sun Ray Mfg., Inc. · Radiology device
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Jul 1980
Decision
67d
Days
Class 2
Risk

K801163 is an FDA 510(k) clearance for the SUNBURST, SUN SYSTEMS OR BC2. Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Sun Ray Mfg., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1980 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 878.4635 - the FDA radiology and imaging software oversight framework. 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 Ray Mfg., Inc. devices

Submission Details

510(k) Number K801163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1980
Decision Date July 21, 1980
Days to Decision 67 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 107d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LEJ Booth, Sun Tan
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4635
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LEJ Booth, Sun Tan

All 80
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