Cleared Traditional

K160584 - Surgical Navigation Advanced Platform (...

K160584 is the FDA 510(k) clearance for Surgical Navigation Advanced Platform (... by Surgical Theater, LLC. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K160584 · Surgical Theater, LLC · Radiology device
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Jun 2016
Decision
119d
Days
Class 2
Risk

K160584 is an FDA 510(k) clearance for the Surgical Navigation Advanced Platform (SNAP). Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Surgical Theater, LLC (Mayfield Village, US). The FDA issued a Cleared decision on June 28, 2016 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Surgical Theater, LLC devices

Submission Details

510(k) Number K160584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2016
Decision Date June 28, 2016
Days to Decision 119 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 107d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1095
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