Cleared Traditional

K827064 - SIEMENS POLYDOROS 800 (FDA 510(k) Clearance)

K827064 · Siemens Medical Solutions USA, Inc. · Radiology device
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Feb 1982
Decision
40d
Days
-
Risk

K827064 is an FDA 510(k) clearance for the SIEMENS POLYDOROS 800.

Submitted by Siemens Medical Solutions USA, Inc. (Issaquah, US). The FDA issued a Cleared decision on February 24, 1982 after a review of 40 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K827064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1982
Decision Date February 24, 1982
Days to Decision 40 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 107d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -