Cleared Traditional

K161322 - CT CoPilot

K161322 is an FDA 510(k) clearance for CT CoPilot, manufactured by Zepmed, LLC. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K161322 · Zepmed, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
210d
Days
Class 2
Risk

K161322 is an FDA 510(k) clearance for the CT CoPilot. 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 Zepmed, LLC (La Jolla, US). The FDA issued a Cleared decision on December 7, 2016 after a review of 210 days - an extended review cycle.

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-to-high 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.

FDA 510(k) Submission Details - K161322

510(k) Number K161322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2016
Decision Date December 07, 2016
Days to Decision 210 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 107d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

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 Consultant

Monroe Medical Device Consulting, LLC
James W. Monroe

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 2273
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K161322.
Multi-Modality Tumor Tracking (MMTT) application
K162955 · Philips Medical Systems Nederland B.V. · Dec 2016
Zia
K160852 · Zetta Medical Technologies, LLC · Dec 2016
CAAS MR 4D Flow
K162376 · Pie Medical Imaging BV · Dec 2016
DENSEEMAMMO v1.0
K152009 · Statlife · Dec 2016
MEDSYNAPSE Zero Footprint Viewer
K163158 · Medsynaptic Private, Ltd. · Dec 2016
ViewPoint 6
K162743 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Nov 2016
K161322 · CT CoPilot
Download PDF FDA Summary Zepmed, LLC