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FDA 510(k)

I-125 RAPID STRAND

K-Number: K940632 · 1994-09-02

ApplicantMedi-Physics Inc. Dba Nycomed Amersham Imaging
Decision Date1994-09-02
Product CodeIWI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

I-125 RAPID STRAND 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 1994-09-02 under 510(k) number K940632. The device is classified under product code IWI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-125 RAPID STRAND?

I-125 RAPID STRAND is a medical device that received FDA 510(k) clearance on 1994-09-02. The listed applicant is Medi-Physics Inc. Dba Nycomed Amersham Imaging. The 510(k) number is K940632.

When did I-125 RAPID STRAND receive FDA 510(k) clearance?

I-125 RAPID STRAND received FDA 510(k) clearance on 1994-09-02, under 510(k) number K940632.

Who is the listed applicant for I-125 RAPID STRAND?

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 RAPID STRAND?

The FDA product code for I-125 RAPID STRAND is IWI.

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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 6733K921961SDMO APPLICATOR CODE: ASN.8236K915156I-125 SEEDS CODE: 6702K914281I-125 SEEDS, CODE: 6711K914268I-125 SEEDS IN CARRIER, CODE: 6720K811677KRYPTON CART

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Related Devices (Code: IWI)

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.

K973363NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633Ml Strategies, Inc.K912170RADIOACTIVE IODINE-125 SOURCESBest IndustriesK882449CESIUM 137 SOURCE, MODEL CSM-40Cis-Us, Inc.K874787MODIFIED PALLADIUM SEED MODEL 100Theragenics Corp.K852542PALLADIUM SEED MODEL 100Nuclear Medicine, Inc.

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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