FDA 510(k)

Adani MammoScan

K-Number: K172027 · 2017-10-20

ApplicantAdani

Decision Date2017-10-20

Product CodeMUE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Adani MammoScan is the device name listed in this FDA 510(k) record. The listed applicant is Adani. It received FDA 510(k) clearance on 2017-10-20 under 510(k) number K172027. 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 Adani MammoScan?

Adani MammoScan is a medical device that received FDA 510(k) clearance on 2017-10-20. The listed applicant is Adani. The 510(k) number is K172027.

When did Adani MammoScan receive FDA 510(k) clearance?

Adani MammoScan received FDA 510(k) clearance on 2017-10-20, under 510(k) number K172027.

Who is the listed applicant for Adani MammoScan?

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

What is the FDA product code for Adani MammoScan?

The FDA product code for Adani MammoScan is MUE.

Other records listing Adani 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.

K200944UNIEXPERT 2 PLUS

Related Devices (Code: MUE)

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 SCS K243420HESTIAGenoray Co., Ltd.K2438492430TCA with Xmaru WRayence Co., Ltd.K241113VIVIX-MVieworks 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.