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FDA 510(k)

OPTISOURCE, MODEL 1032P

K-Number: K040766 · 2004-07-22

ApplicantInternational Brachytherapy S.A.
Decision Date2004-07-22
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPTISOURCE, MODEL 1032P is the device name listed in this FDA 510(k) record. The listed applicant is International Brachytherapy S.A.. It received FDA 510(k) clearance on 2004-07-22 under 510(k) number K040766. 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 OPTISOURCE, MODEL 1032P?

OPTISOURCE, MODEL 1032P is a medical device that received FDA 510(k) clearance on 2004-07-22. The listed applicant is International Brachytherapy S.A.. The 510(k) number is K040766.

When did OPTISOURCE, MODEL 1032P receive FDA 510(k) clearance?

OPTISOURCE, MODEL 1032P received FDA 510(k) clearance on 2004-07-22, under 510(k) number K040766.

Who is the listed applicant for OPTISOURCE, MODEL 1032P?

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

What is the FDA product code for OPTISOURCE, MODEL 1032P?

The FDA product code for OPTISOURCE, MODEL 1032P is KXK.

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Other records listing International Brachytherapy S.A. 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.

K973328INTERSOURCE

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.

K252296OncoPatchOncopatch, Inc.K242818IsoSphereIsoaid, LLCK223465RadianceTx Radionuclide Brachytherapy SourceRadiance Therapeutics, Inc.K221539GammaTileGt Medical TechnologiesK202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceLv Liberty Vision Corporation

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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