Digimamo D

FDA 510(k) K210151 · Vmi Tecnologias Ltda

Substantially Equivalent

510(k) numberK210151

Submission

Device name
Digimamo D
Applicant
Vmi Tecnologias Ltda
Lagoa Santa, BR
Received
January 21, 2021
Decision date
March 1, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MUE – Full Field Digital, System, X-Ray, Mammographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1715
Specialty
Radiology

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K254090I-View®MUE · Traditional Hologic, Inc.09/02/2026SE
K253678MAMMOMAT B.brilliant (11372950)MUE · Traditional Siemens Medical Solutions USA, Inc.06/18/2026SE
K254092Bellalun 2D (VDMS-1000S)MUE · Traditional Vieworks Co., Ltd.05/28/2026SE
K260087Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightMUE · Traditional GE Medical Systems SCS03/24/2026SE
K243420HestiaMUE · Traditional Genoray Co., Ltd.07/17/2025SE
K2438492430TCA with Xmaru WMUE · Special Rayence Co., Ltd.03/12/2025SE
K241113Vivix-MMUE · Traditional Vieworks Co., Ltd.01/16/2025SE
K233539MAMMOMAT B.brilliantMUE · Traditional Siemens Medical Solutions USA, Inc.03/27/2024SE
K220073RMF-2000MUE · Traditional DRTECH Corporation01/26/2023SE
K211720Planmed Clarity 2D, Planmed Clarify SMUE · Traditional Planmed OY07/18/2022SE

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Questions and answers

When was Digimamo D cleared by the FDA?

Digimamo D (K210151) received a 510(k) decision of Substantially Equivalent on March 1, 2022, 404 days after the submission was received.

What is the product code of K210151?

The FDA product code is MUE – Full Field Digital, System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1715.