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FDA 510(k)

IMAGYN 125 I SEED, MODEL IS 125

K-Number: K982421 · 1998-07-31

ApplicantInternational Isotopes, Inc.
Decision Date1998-07-31
Product CodeIWG
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGYN 125 I SEED, MODEL IS 125 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 1998-07-31 under 510(k) number K982421. The device is classified under product code IWG. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGYN 125 I SEED, MODEL IS 125?

IMAGYN 125 I SEED, MODEL IS 125 is a medical device that received FDA 510(k) clearance on 1998-07-31. The listed applicant is International Isotopes, Inc.. The 510(k) number is K982421.

When did IMAGYN 125 I SEED, MODEL IS 125 receive FDA 510(k) clearance?

IMAGYN 125 I SEED, MODEL IS 125 received FDA 510(k) clearance on 1998-07-31, under 510(k) number K982421.

Who is the listed applicant for IMAGYN 125 I SEED, MODEL IS 125?

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 IMAGYN 125 I SEED, MODEL IS 125?

The FDA product code for IMAGYN 125 I SEED, MODEL IS 125 is IWG.

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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.

K992963I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401

Related Devices (Code: IWG)

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.

K081066BRACHYTHERAPY SOURCE DEVICE, MODEL 9011Medi-Physics, Inc., Dba GE HealthcareK834027GOLD SEADSRadiation Safety & Nuclear Products, Inc.

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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