Cleared Traditional

K827370 - IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM (FDA 510(k) Clearance)

K827370 · Irex Corp. · Radiology device
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Jun 1982
Decision
77d
Days
-
Risk

K827370 is an FDA 510(k) clearance for the IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM.

Submitted by Irex Corp. (Ramsey, US). The FDA issued a Cleared decision on June 28, 1982 after a review of 77 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 Irex Corp. devices

Submission Details

510(k) Number K827370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1982
Decision Date June 28, 1982
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 107d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -