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FDA 510(k)

BIOLUCENT APPLICATOR KIT

K-Number: K062830 · 2006-10-20

ApplicantBiolucent, Inc.
Decision Date2006-10-20
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BIOLUCENT APPLICATOR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biolucent, Inc.. It received FDA 510(k) clearance on 2006-10-20 under 510(k) number K062830. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOLUCENT APPLICATOR KIT?

BIOLUCENT APPLICATOR KIT is a medical device that received FDA 510(k) clearance on 2006-10-20. The listed applicant is Biolucent, Inc.. The 510(k) number is K062830.

When did BIOLUCENT APPLICATOR KIT receive FDA 510(k) clearance?

BIOLUCENT APPLICATOR KIT received FDA 510(k) clearance on 2006-10-20, under 510(k) number K062830.

Who is the listed applicant for BIOLUCENT APPLICATOR KIT?

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 BIOLUCENT APPLICATOR KIT?

The FDA product code for BIOLUCENT APPLICATOR KIT is JAQ.

Related Clinical Trials

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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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 KITK062141MAMMOPAD RADIOLUCENT CUSHIONK061241BIOLUCENT APPLICATOR, MODEL RTA-XXK053595CURAY CUSTOM SEED ARRAYK003795BIOLUCENT MAMMOGRAPHY CUSHION

Related Devices (Code: JAQ)

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.

K262383LumenCare AzureNucletron B.V.K252717MAASTRO Rectal Applicator SetVarian Medical SystemsK251037Rectal ApplicatorNucletron B.V.K252884Guided Aarhus Applicator SetVarian Medical SystemsK250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc.K250289Intracavitary/Interstitial SystemVarian Medical Systems

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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