IPACS MEDICAL IMAGE MANAGEMENT SYSTEM— 510(k) K140797

Substantially Equivalent

Visbion Limited

FDA 510(k) clearance K140797 for IPACS MEDICAL IMAGE MANAGEMENT SYSTEM, Substantially Equivalent on 2014-12-12. Applicant: Visbion Limited.

Clearance details

Applicant: Visbion Limited
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2014-03-31
Decision date: 2014-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chertsey, Surrey, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.