PLANMED VERITY— 510(k) K121418

Name: FDA 510(k) clearance K121418
Creator: U.S. Food and Drug Administration
Published: 2013-02-01

Substantially Equivalent

Planmed OY

FDA 510(k) clearance K121418 for PLANMED VERITY, Substantially Equivalent on 2013-02-01. Applicant: Planmed OY. Device class: 2.

Clearance details

Applicant: Planmed OY
Product code: Code JAK
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2012-05-11
Decision date: 2013-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

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K253770 — CardIQ Suite2026-07-21
K253560 — Enhanced Boundary for PCCT2026-06-24
K253026 — Respiratory Gating for Scanners (2.1)2026-06-04

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 JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.