DIGORA OPTIME (OR DIGORA ONTIME)— 510(k) K041050

Name: FDA 510(k) clearance K041050
Creator: U.S. Food and Drug Administration
Published: 2004-06-15

Substantially Equivalent

Soredex Palodex Group OY

FDA 510(k) clearance K041050 for DIGORA OPTIME (OR DIGORA ONTIME), Substantially Equivalent on 2004-06-15. Applicant: Soredex Palodex Group OY. Device class: 2.

Clearance details

Applicant: Soredex Palodex Group OY
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2004-04-22
Decision date: 2004-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

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Recalls naming K041050

K-number listed on FDA's recall record

Z-0839-2020 — Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)Class II·Terminated·Palodex Group Oy·20200107
Z-0840-2020 — Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)Class II·Terminated·Palodex Group Oy·20200107
Z-0841-2020 — KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)Class II·Terminated·Palodex Group Oy·20200107
Z-0842-2020 — Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)Class II·Terminated·Palodex Group Oy·20200107

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041050.

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