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)

CURA COLLIMATOR

K-Number: K123893 · 2013-03-04

Decision Date2013-03-04
Product CodeIXI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CURA COLLIMATOR is the device name listed in this FDA 510(k) record. The listed applicant is Cura Medical Technologies, LLC. It received FDA 510(k) clearance on 2013-03-04 under 510(k) number K123893. The device is classified under product code IXI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CURA COLLIMATOR?

CURA COLLIMATOR is a medical device that received FDA 510(k) clearance on 2013-03-04. The listed applicant is Cura Medical Technologies, LLC. The 510(k) number is K123893.

When did CURA COLLIMATOR receive FDA 510(k) clearance?

CURA COLLIMATOR received FDA 510(k) clearance on 2013-03-04, under 510(k) number K123893.

Who is the listed applicant for CURA COLLIMATOR?

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

What is the FDA product code for CURA COLLIMATOR?

The FDA product code for CURA COLLIMATOR is IXI.

Related Clinical Trials

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.

Other records listing Cura Medical Technologies, LLC as applicant

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.

Related Devices (Code: IXI)

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.

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.

↑