Cleared Traditional

K161507 - Cianna Medical SAVI Scout Reflector and SAVI Scout System (FDA 510(k) Clearance)

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

K161507 · Cianna Medical, Inc. · Radiology device
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Jul 2016
Decision
58d
Days
Class 2
Risk

K161507 is an FDA 510(k) clearance for the Cianna Medical SAVI Scout Reflector and SAVI Scout 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 July 29, 2016 after a review of 58 days - a notably fast clearance cycle.

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: 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 Cianna Medical, Inc. devices

Submission Details

510(k) Number K161507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2016
Decision Date July 29, 2016
Days to Decision 58 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
49d faster than avg
Panel avg: 107d · This submission: 58d
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.