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FDA 510(k)

BIOLUCENT MAMMOGRAPHY CUSHION

K-Number: K003795 · 2001-02-14

ApplicantBiolucent, Inc.
Decision Date2001-02-14
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BIOLUCENT MAMMOGRAPHY CUSHION is the device name listed in this FDA 510(k) record. The listed applicant is Biolucent, Inc.. It received FDA 510(k) clearance on 2001-02-14 under 510(k) number K003795. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOLUCENT MAMMOGRAPHY CUSHION?

BIOLUCENT MAMMOGRAPHY CUSHION is a medical device that received FDA 510(k) clearance on 2001-02-14. The listed applicant is Biolucent, Inc.. The 510(k) number is K003795.

When did BIOLUCENT MAMMOGRAPHY CUSHION receive FDA 510(k) clearance?

BIOLUCENT MAMMOGRAPHY CUSHION received FDA 510(k) clearance on 2001-02-14, under 510(k) number K003795.

Who is the listed applicant for BIOLUCENT MAMMOGRAPHY CUSHION?

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 MAMMOGRAPHY CUSHION?

The FDA product code for BIOLUCENT MAMMOGRAPHY CUSHION is IZH.

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 KITK062830BIOLUCENT APPLICATOR KITK062141MAMMOPAD RADIOLUCENT CUSHIONK061241BIOLUCENT APPLICATOR, MODEL RTA-XXK053595CURAY CUSTOM SEED ARRAY

Related Devices (Code: IZH)

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.

K203509SMART FINDERIms Giotto S.P.A.K202294Affirm Contrast BiopsyHologic, Inc.K191495Biopsy PositionerFujifilm CorporationK161575Affirm Lateral Arm Upright Biopsy AccessoryHologicK161920Comfort CoverPrecision Dynamics CorporationK153486Affirm Prone Biopsy SystemHologic, Inc.

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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