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FDA 510(k)

Digimamo D

K-Number: K210151 · 2022-03-01

ApplicantVmi Tecnologias Ltda
Decision Date2022-03-01
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Digimamo D is the device name listed in this FDA 510(k) record. The listed applicant is Vmi Tecnologias Ltda. It received FDA 510(k) clearance on 2022-03-01 under 510(k) number K210151. 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 Digimamo D?

Digimamo D is a medical device that received FDA 510(k) clearance on 2022-03-01. The listed applicant is Vmi Tecnologias Ltda. The 510(k) number is K210151.

When did Digimamo D receive FDA 510(k) clearance?

Digimamo D received FDA 510(k) clearance on 2022-03-01, under 510(k) number K210151.

Who is the listed applicant for Digimamo D?

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

What is the FDA product code for Digimamo D?

The FDA product code for Digimamo D is MUE.

Other records listing Vmi Tecnologias Ltda 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.

K202388Apolo D / Apolo SK201340AQUILA 320 D / AQUILA 320 S

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.

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.K241113VIVIX-MVieworks 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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