Cleared Traditional

K141318 - CIANNA MEDICAL SGS SYSTEM (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K141318 · Cianna Medical, Inc. · Radiology device
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Aug 2014
Decision
99d
Days
Class 2
Risk

K141318 is an FDA 510(k) clearance for the CIANNA MEDICAL SGS SYSTEM. Classified as Internal Tissue Marker (product code PDW), Class II - Special Controls.

Submitted by Cianna Medical, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on August 27, 2014 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 878.4670 - the FDA radiology and imaging software oversight framework. 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 Cianna Medical, Inc. devices

Submission Details

510(k) Number K141318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2014
Decision Date August 27, 2014
Days to Decision 99 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 107d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDW Internal Tissue Marker
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4670
Definition An Internal Tissue Marker Is A Prescription Use Device That Is Intended For Use Prior To Or During General Surgical Procedures To Demarcate Selected Sites On Internal Tissues.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.