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FDA 510(k)

GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L

K-Number: K111434 · 2011-10-27

ApplicantGiotto USA, LLC
Decision Date2011-10-27
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L is the device name listed in this FDA 510(k) record. The listed applicant is Giotto USA, LLC. It received FDA 510(k) clearance on 2011-10-27 under 510(k) number K111434. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L?

GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L is a medical device that received FDA 510(k) clearance on 2011-10-27. The listed applicant is Giotto USA, LLC. The 510(k) number is K111434.

When did GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L receive FDA 510(k) clearance?

GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L received FDA 510(k) clearance on 2011-10-27, under 510(k) number K111434.

Who is the listed applicant for GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L?

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

What is the FDA product code for GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L?

The FDA product code for GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L is MUE.

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Other records listing Giotto USA, LLC 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.

K113607BIOPSY DIGIT S BIOPSY SLK062039BIOPSY DIGIT-AM

Related Devices (Code: MUE)

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.

K254090I-View®Hologic, Inc.K253678MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc.K254092Bellalun 2D (VDMS-1000S)Vieworks Co., Ltd.K260087Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightGE Medical Systems SCSK243420HESTIAGenoray Co., Ltd.K2438492430TCA with Xmaru WRayence Co., Ltd.

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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