Cleared Traditional

SPIRAFLOW 2001, MULTI-DIRECTIONAL TOMOGRAPHIC UNIT (K827346) - FDA 510(k) Clearance

K827346 · Rayflow Italia S.R.L. · Radiology device
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Feb 1983
Decision
54d
Days
-
Risk

K827346 is an FDA 510(k) clearance for the SPIRAFLOW 2001, MULTI-DIRECTIONAL TOMOGRAPHIC UNIT.

Submitted by Rayflow Italia S.R.L. (Walker, US). The FDA issued a Cleared decision on February 14, 1983 after a review of 54 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 Rayflow Italia S.R.L. devices

Submission Details

510(k) Number K827346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1982
Decision Date February 14, 1983
Days to Decision 54 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 107d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -