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FDA 510(k)

GIOTTO PATIENT BED

K-Number: K925212 · 1993-01-15

ApplicantGold Coast Imaging, Inc.
Decision Date1993-01-15
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GIOTTO PATIENT BED 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 1993-01-15 under 510(k) number K925212. 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 GIOTTO PATIENT BED?

GIOTTO PATIENT BED is a medical device that received FDA 510(k) clearance on 1993-01-15. The listed applicant is Gold Coast Imaging, Inc.. The 510(k) number is K925212.

When did GIOTTO PATIENT BED receive FDA 510(k) clearance?

GIOTTO PATIENT BED received FDA 510(k) clearance on 1993-01-15, under 510(k) number K925212.

Who is the listed applicant for GIOTTO PATIENT BED?

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 GIOTTO PATIENT BED?

The FDA product code for GIOTTO PATIENT BED is IZH.

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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.

K933430CYTOGUIDE STEREOTATIC BIOPSY SYSTEM

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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