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FDA 510(k)

SENOGRAPHE DS, SENOGRAPHE ESSENTIAL

K-Number: K110798 · 2011-12-22

ApplicantGeneral Electric Company
Decision Date2011-12-22
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SENOGRAPHE DS, SENOGRAPHE ESSENTIAL is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Company. It received FDA 510(k) clearance on 2011-12-22 under 510(k) number K110798. 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 SENOGRAPHE DS, SENOGRAPHE ESSENTIAL?

SENOGRAPHE DS, SENOGRAPHE ESSENTIAL is a medical device that received FDA 510(k) clearance on 2011-12-22. The listed applicant is General Electric Company. The 510(k) number is K110798.

When did SENOGRAPHE DS, SENOGRAPHE ESSENTIAL receive FDA 510(k) clearance?

SENOGRAPHE DS, SENOGRAPHE ESSENTIAL received FDA 510(k) clearance on 2011-12-22, under 510(k) number K110798.

Who is the listed applicant for SENOGRAPHE DS, SENOGRAPHE ESSENTIAL?

The FDA 510(k) record lists General Electric Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENOGRAPHE DS, SENOGRAPHE ESSENTIAL?

The FDA product code for SENOGRAPHE DS, SENOGRAPHE ESSENTIAL is MUE.

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Other records listing General Electric Company 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.

K103485SENOGRAPH DS, SENOGRAPH ESSENSTIAL

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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