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FDA 510(k)

CYTOGUIDE STEREOTATIC BIOPSY SYSTEM

K-Number: K933430 · 1994-09-22

ApplicantGold Coast Imaging, Inc.
Decision Date1994-09-22
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CYTOGUIDE STEREOTATIC BIOPSY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gold Coast Imaging, Inc.. It received FDA 510(k) clearance on 1994-09-22 under 510(k) number K933430. 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 CYTOGUIDE STEREOTATIC BIOPSY SYSTEM?

CYTOGUIDE STEREOTATIC BIOPSY SYSTEM is a medical device that received FDA 510(k) clearance on 1994-09-22. The listed applicant is Gold Coast Imaging, Inc.. The 510(k) number is K933430.

When did CYTOGUIDE STEREOTATIC BIOPSY SYSTEM receive FDA 510(k) clearance?

CYTOGUIDE STEREOTATIC BIOPSY SYSTEM received FDA 510(k) clearance on 1994-09-22, under 510(k) number K933430.

Who is the listed applicant for CYTOGUIDE STEREOTATIC BIOPSY SYSTEM?

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

What is the FDA product code for CYTOGUIDE STEREOTATIC BIOPSY SYSTEM?

The FDA product code for CYTOGUIDE STEREOTATIC BIOPSY SYSTEM 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 Gold Coast Imaging, 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.

K925212GIOTTO PATIENT BED

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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