Cleared Traditional

K827086 - LATERAL ANGULATING FLUORO SUSPENSION (FDA 510(k) Clearance)

K827086 · General Electric Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1982
Decision
33d
Days
-
Risk

K827086 is an FDA 510(k) clearance for the LATERAL ANGULATING FLUORO SUSPENSION.

Submitted by General Electric Co. (Schenectady, US). The FDA issued a Cleared decision on February 24, 1982 after a review of 33 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 General Electric Co. devices

Submission Details

510(k) Number K827086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1982
Decision Date February 24, 1982
Days to Decision 33 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 107d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -