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FDA 510(k)

I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401

K-Number: K992963 · 1999-09-21

ApplicantInternational Isotopes, Inc.
Decision Date1999-09-21
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401 is the device name listed in this FDA 510(k) record. The listed applicant is International Isotopes, Inc.. It received FDA 510(k) clearance on 1999-09-21 under 510(k) number K992963. 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 I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401?

I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401 is a medical device that received FDA 510(k) clearance on 1999-09-21. The listed applicant is International Isotopes, Inc.. The 510(k) number is K992963.

When did I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401 receive FDA 510(k) clearance?

I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401 received FDA 510(k) clearance on 1999-09-21, under 510(k) number K992963.

Who is the listed applicant for I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401?

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

What is the FDA product code for I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401?

The FDA product code for I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401 is KXK.

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Other records listing International Isotopes, Inc. 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.

K982421IMAGYN 125 I SEED, MODEL IS 125

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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