Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CT CoPilot

K-Number: K161322 · 2016-12-07

ApplicantZepmed, LLC
Decision Date2016-12-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT CoPilot is the device name listed in this FDA 510(k) record. The listed applicant is Zepmed, LLC. It received FDA 510(k) clearance on 2016-12-07 under 510(k) number K161322. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CT CoPilot?

CT CoPilot is a medical device that received FDA 510(k) clearance on 2016-12-07. The listed applicant is Zepmed, LLC. The 510(k) number is K161322.

When did CT CoPilot receive FDA 510(k) clearance?

CT CoPilot received FDA 510(k) clearance on 2016-12-07, under 510(k) number K161322.

Who is the listed applicant for CT CoPilot?

The FDA 510(k) record lists Zepmed, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT CoPilot?

The FDA product code for CT CoPilot is LLZ.

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.K260500ResolutionMDResolutionMD, Inc.K262120Avara ViewerAvara Software

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑