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FDA 510(k)

CURAY CUSTOM SEED ARRAY

K-Number: K053595 · 2006-02-28

ApplicantBiolucent, Inc.
Decision Date2006-02-28
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CURAY CUSTOM SEED ARRAY is the device name listed in this FDA 510(k) record. The listed applicant is Biolucent, Inc.. It received FDA 510(k) clearance on 2006-02-28 under 510(k) number K053595. 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 CURAY CUSTOM SEED ARRAY?

CURAY CUSTOM SEED ARRAY is a medical device that received FDA 510(k) clearance on 2006-02-28. The listed applicant is Biolucent, Inc.. The 510(k) number is K053595.

When did CURAY CUSTOM SEED ARRAY receive FDA 510(k) clearance?

CURAY CUSTOM SEED ARRAY received FDA 510(k) clearance on 2006-02-28, under 510(k) number K053595.

Who is the listed applicant for CURAY CUSTOM SEED ARRAY?

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

What is the FDA product code for CURAY CUSTOM SEED ARRAY?

The FDA product code for CURAY CUSTOM SEED ARRAY is KXK.

Related Clinical Trials

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Other records listing Biolucent, Inc. 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.

K070659BIOLUCENT APPLICATOR KITK062830BIOLUCENT APPLICATOR KITK062141MAMMOPAD RADIOLUCENT CUSHIONK061241BIOLUCENT APPLICATOR, MODEL RTA-XXK003795BIOLUCENT MAMMOGRAPHY CUSHION

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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