K212230

Substantially Equivalent

TruSPECT Radiological Image Processing Station

Applicant: Spectrum Dynamics Medical, Ltd.
Product code: LLZ
Advisory panel: Radiology
Date received: 2021-07-16
Decision date: 2021-08-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Caesarea, IL

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.