PLANNED SOPHIED CLASSIC— 510(k) K962105

Substantially Equivalent

Planmed OY

FDA 510(k) clearance K962105 for PLANNED SOPHIED CLASSIC, Substantially Equivalent on 1997-02-05. Applicant: Planmed OY. Device class: 2.

Clearance details

Applicant: Planmed OY
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1996-05-31
Decision date: 1997-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZH

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K161575 — Affirm Lateral Arm Upright Biopsy Accessory2016-08-10
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More clearances from Planmed OY

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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

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