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FDA 510(k)

PRE-LOADED GOLD VISICOIL CK MARKER

K-Number: K120859 · 2012-04-19

ApplicantRadiomed Corporation
Decision Date2012-04-19
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PRE-LOADED GOLD VISICOIL CK MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Radiomed Corporation. It received FDA 510(k) clearance on 2012-04-19 under 510(k) number K120859. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRE-LOADED GOLD VISICOIL CK MARKER?

PRE-LOADED GOLD VISICOIL CK MARKER is a medical device that received FDA 510(k) clearance on 2012-04-19. The listed applicant is Radiomed Corporation. The 510(k) number is K120859.

When did PRE-LOADED GOLD VISICOIL CK MARKER receive FDA 510(k) clearance?

PRE-LOADED GOLD VISICOIL CK MARKER received FDA 510(k) clearance on 2012-04-19, under 510(k) number K120859.

Who is the listed applicant for PRE-LOADED GOLD VISICOIL CK MARKER?

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

What is the FDA product code for PRE-LOADED GOLD VISICOIL CK MARKER?

The FDA product code for PRE-LOADED GOLD VISICOIL CK MARKER is KXK.

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Other records listing Radiomed Corporation 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.

K161724Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)K070305PRE-LOADED VISICOILK022326RADIOMED MARKERK013660GENETRA

Related Devices (Code: KXK)

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.

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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.

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