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FDA 510(k)

I-SEED

K-Number: K103319 · 2011-01-03

ApplicantTheragenics Corp.
Decision Date2011-01-03
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

I-SEED is the device name listed in this FDA 510(k) record. The listed applicant is Theragenics Corp.. It received FDA 510(k) clearance on 2011-01-03 under 510(k) number K103319. 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 I-SEED?

I-SEED is a medical device that received FDA 510(k) clearance on 2011-01-03. The listed applicant is Theragenics Corp.. The 510(k) number is K103319.

When did I-SEED receive FDA 510(k) clearance?

I-SEED received FDA 510(k) clearance on 2011-01-03, under 510(k) number K103319.

Who is the listed applicant for I-SEED?

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

What is the FDA product code for I-SEED?

The FDA product code for I-SEED is KXK.

Other records listing Theragenics Corp. 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.

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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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