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FDA 510(k)

I-125 SEEDS, CODE: 6711

K-Number: K914281 · 1991-11-22

ApplicantMedi-Physics Inc. Dba Nycomed Amersham Imaging
Decision Date1991-11-22
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

I-125 SEEDS, CODE: 6711 is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Physics Inc. Dba Nycomed Amersham Imaging. It received FDA 510(k) clearance on 1991-11-22 under 510(k) number K914281. 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-125 SEEDS, CODE: 6711?

I-125 SEEDS, CODE: 6711 is a medical device that received FDA 510(k) clearance on 1991-11-22. The listed applicant is Medi-Physics Inc. Dba Nycomed Amersham Imaging. The 510(k) number is K914281.

When did I-125 SEEDS, CODE: 6711 receive FDA 510(k) clearance?

I-125 SEEDS, CODE: 6711 received FDA 510(k) clearance on 1991-11-22, under 510(k) number K914281.

Who is the listed applicant for I-125 SEEDS, CODE: 6711?

The FDA 510(k) record lists Medi-Physics Inc. Dba Nycomed Amersham Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-125 SEEDS, CODE: 6711?

The FDA product code for I-125 SEEDS, CODE: 6711 is KXK.

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Other records listing Medi-Physics Inc. Dba Nycomed Amersham Imaging 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.

K010821ECHOSEED/IODINE-125 SEEDS, MODEL 6733K940632I-125 RAPID STRANDK921961SDMO APPLICATOR CODE: ASN.8236K915156I-125 SEEDS CODE: 6702K914268I-125 SEEDS IN CARRIER, CODE: 6720K811677KRYPTON CART

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Related Devices (Code: KXK)

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Official Source

View on FDA Database →

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

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