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FDA 510(k)

SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)

K-Number: K131885 · 2013-09-26

ApplicantGE Medical Systems SCS
Decision Date2013-09-26
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI) is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems SCS. It received FDA 510(k) clearance on 2013-09-26 under 510(k) number K131885. 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 ESSENTIAL, PREMIUM VIEW I (PVI)?

SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI) is a medical device that received FDA 510(k) clearance on 2013-09-26. The listed applicant is GE Medical Systems SCS. The 510(k) number is K131885.

When did SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI) receive FDA 510(k) clearance?

SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI) received FDA 510(k) clearance on 2013-09-26, under 510(k) number K131885.

Who is the listed applicant for SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)?

The FDA 510(k) record lists GE Medical Systems SCS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)?

The FDA product code for SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI) is MUE.

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Other records listing GE Medical Systems SCS 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.

K253770CardIQ SuiteK260087Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightK251199Allia MoveoK243672CardIQ SuiteK243651VersaViewerK2434463DXR

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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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