Cleared Traditional

K827371 - CILCO ASCAN (FDA 510(k) Clearance)

K827371 · Cilco, Inc. · Radiology device
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Jul 1982
Decision
102d
Days
-
Risk

K827371 is an FDA 510(k) clearance for the CILCO ASCAN.

Submitted by Cilco, Inc. (Huntington, US). The FDA issued a Cleared decision on July 9, 1982 after a review of 102 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cilco, Inc. devices

Submission Details

510(k) Number K827371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1982
Decision Date July 09, 1982
Days to Decision 102 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 107d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -