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FDA 510(k)

Planmed Clarity 2D, Planmed Clarify S

K-Number: K211720 · 2022-07-18

ApplicantPlanmed OY
Decision Date2022-07-18
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Planmed Clarity 2D, Planmed Clarify S is the device name listed in this FDA 510(k) record. The listed applicant is Planmed OY. It received FDA 510(k) clearance on 2022-07-18 under 510(k) number K211720. 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 Planmed Clarity 2D, Planmed Clarify S?

Planmed Clarity 2D, Planmed Clarify S is a medical device that received FDA 510(k) clearance on 2022-07-18. The listed applicant is Planmed OY. The 510(k) number is K211720.

When did Planmed Clarity 2D, Planmed Clarify S receive FDA 510(k) clearance?

Planmed Clarity 2D, Planmed Clarify S received FDA 510(k) clearance on 2022-07-18, under 510(k) number K211720.

Who is the listed applicant for Planmed Clarity 2D, Planmed Clarify S?

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

What is the FDA product code for Planmed Clarity 2D, Planmed Clarify S?

The FDA product code for Planmed Clarity 2D, Planmed Clarify S is MUE.

Other records listing Planmed OY 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.

K250318Planmed XFIK213278Planmed VerityK192317Planmed Clarity 2D and Clarity SK180918Planmed VerityK163328Planmed Clarity

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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