Computer Vision AG

FDA Device Registration & Listing · Wallisellen Zurich, CH · Registration 3042928350

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3042928350
FEI Number
3042928350
Entity Name
Computer Vision AG
City/State/Country
Wallisellen Zurich, CH
Establishment Address
Zwicky-Platz 1, Wallisellen Zurich 8304, CH
Establishment Type(s)
Foreign Private Label Distributor,Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Computer Vision AG (Owner Number: 10094920)
Owner / Operator Contact Address
Zwicky-Platz 1, Wallisellen, CH-ZH 8304, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Emeralgo Ortho L-Spine MR-Q

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2026-01-06

Official Correspondent

No official correspondent registered.

US Agent Details

Rene Balzano Business: Emeralgo Inc. Email: info@emeralgo.com Phone: (813) 5709797

Related Public Records

Same Entity

Computer Vision AG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K242270 Orthofix Srl OrthoNext Platform System 2024-12-19
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042928350. Last updated year: 2026. Please use registration number 3042928350 when referencing this establishment in official correspondence.
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