Cleared Traditional

UVATEC SUNTAMED 4000 AND 2000 (K828671) - FDA 510(k) Clearance

K828671 · Solitec GmbH · Radiology device
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Jan 1983
Decision
50d
Days
-
Risk

K828671 is an FDA 510(k) clearance for the UVATEC SUNTAMED 4000 AND 2000.

Submitted by Solitec GmbH (Planegg, DE). The FDA issued a Cleared decision on January 19, 1983 after a review of 50 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.

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Submission Details

510(k) Number K828671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1982
Decision Date January 19, 1983
Days to Decision 50 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 107d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -