Planmed Clarity— 510(k) K163328

Name: FDA 510(k) clearance K163328
Creator: U.S. Food and Drug Administration
Published: 2017-12-28

Substantially Equivalent

Planmed OY

FDA 510(k) clearance K163328 for Planmed Clarity, Substantially Equivalent on 2017-12-28. Applicant: Planmed OY. Device class: 2.

Clearance details

Applicant: Planmed OY
Product code: Code MUE
Device class: Class 2
Regulation: 21 CFR 892.1715
Advisory panel: Radiology
Date received: 2016-11-28
Decision date: 2017-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

Recent devices under product code MUE

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K254090 — I-View®2026-09-02
K253678 — MAMMOMAT B.brilliant (11372950)2026-06-18
K254092 — Bellalun 2D (VDMS-1000S)2026-05-28
K260087 — Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright2026-03-24
K243420 — HESTIA2025-07-17

More clearances from Planmed OY

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K250318 — Planmed XFI2025-09-26
K211720 — Planmed Clarity 2D, Planmed Clarify S2022-07-18
K213278 — Planmed Verity2022-04-28
K192317 — Planmed Clarity 2D and Clarity S2020-10-23
K180918 — Planmed Verity2018-11-30

Adverse events under product code MUE

product code MUE

Death: 5
Other: 1
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.