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FDA 510(k)

PLANMED NUANCE DIGIGUIDE

K-Number: K121963 · 2012-11-21

ApplicantPlanmed OY
Decision Date2012-11-21
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PLANMED NUANCE DIGIGUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Planmed OY. It received FDA 510(k) clearance on 2012-11-21 under 510(k) number K121963. 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 NUANCE DIGIGUIDE?

PLANMED NUANCE DIGIGUIDE is a medical device that received FDA 510(k) clearance on 2012-11-21. The listed applicant is Planmed OY. The 510(k) number is K121963.

When did PLANMED NUANCE DIGIGUIDE receive FDA 510(k) clearance?

PLANMED NUANCE DIGIGUIDE received FDA 510(k) clearance on 2012-11-21, under 510(k) number K121963.

Who is the listed applicant for PLANMED NUANCE DIGIGUIDE?

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 NUANCE DIGIGUIDE?

The FDA product code for PLANMED NUANCE DIGIGUIDE is MUE.

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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 XFIK211720Planmed Clarity 2D, Planmed Clarify SK213278Planmed VerityK192317Planmed Clarity 2D and Clarity SK180918Planmed VerityK163328Planmed Clarity

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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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