Chrysalis Intelligence · Sponsors · De Gotzen S.R.L.

De Gotzen S.R.L.

Olgiate Olona, IT · 3 510(k) clearances

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
3
2020-02-11 → 2020-11-18
Last 12 months
0
Product codes
3
Most recent
2020-11-18
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OAS X-Ray, Tomography, Computed, Dental Class II Radiology 1 2020-11-18
MUH System, X-Ray, Extraoral Source, Digital Class II Dental 1 2020-02-20
LLZ System, Image Processing, Radiological Class II Radiology 1 2020-02-11
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2020-11-18 K201382 X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) OAS Class II Radiology
2020-02-20 K191719 X-MIND Trium MUH Class II Dental
2020-02-11 K192165 Acteon Imaging Suite LLZ Class II Radiology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence