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FDA 510(k)

SENOGRAPH DS, SENOGRAPH ESSENSTIAL

K-Number: K103485 · 2011-10-06

ApplicantGeneral Electric Company
Decision Date2011-10-06
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SENOGRAPH DS, SENOGRAPH ESSENSTIAL 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 2011-10-06 under 510(k) number K103485. 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 SENOGRAPH DS, SENOGRAPH ESSENSTIAL?

SENOGRAPH DS, SENOGRAPH ESSENSTIAL is a medical device that received FDA 510(k) clearance on 2011-10-06. The listed applicant is General Electric Company. The 510(k) number is K103485.

When did SENOGRAPH DS, SENOGRAPH ESSENSTIAL receive FDA 510(k) clearance?

SENOGRAPH DS, SENOGRAPH ESSENSTIAL received FDA 510(k) clearance on 2011-10-06, under 510(k) number K103485.

Who is the listed applicant for SENOGRAPH DS, SENOGRAPH ESSENSTIAL?

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 SENOGRAPH DS, SENOGRAPH ESSENSTIAL?

The FDA product code for SENOGRAPH DS, SENOGRAPH ESSENSTIAL is MUE.

Related Clinical Trials

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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.

K110798SENOGRAPHE DS, SENOGRAPHE ESSENTIAL

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

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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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