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FDA 510(k)

ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125

K-Number: K011205 · 2001-07-10

ApplicantIsoaid
Decision Date2001-07-10
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 is the device name listed in this FDA 510(k) record. The listed applicant is Isoaid. It received FDA 510(k) clearance on 2001-07-10 under 510(k) number K011205. 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 ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125?

ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 is a medical device that received FDA 510(k) clearance on 2001-07-10. The listed applicant is Isoaid. The 510(k) number is K011205.

When did ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 receive FDA 510(k) clearance?

ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 received FDA 510(k) clearance on 2001-07-10, under 510(k) number K011205.

Who is the listed applicant for ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125?

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

What is the FDA product code for ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125?

The FDA product code for ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 is KXK.

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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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