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FDA 510(k)

GENETRA

K-Number: K013660 · 2001-12-05

ApplicantRadiomed Corporation
Decision Date2001-12-05
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GENETRA is the device name listed in this FDA 510(k) record. The listed applicant is Radiomed Corporation. It received FDA 510(k) clearance on 2001-12-05 under 510(k) number K013660. 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 GENETRA?

GENETRA is a medical device that received FDA 510(k) clearance on 2001-12-05. The listed applicant is Radiomed Corporation. The 510(k) number is K013660.

When did GENETRA receive FDA 510(k) clearance?

GENETRA received FDA 510(k) clearance on 2001-12-05, under 510(k) number K013660.

Who is the listed applicant for GENETRA?

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 GENETRA?

The FDA product code for GENETRA 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)K120859PRE-LOADED GOLD VISICOIL CK MARKERK070305PRE-LOADED VISICOILK022326RADIOMED MARKER

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

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

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