PICTOOLS MEDICAL TOOL KIT MODEL 1.0— 510(k) K982146

Substantially Equivalent

Pegasus Imaging Corp.

FDA 510(k) clearance K982146 for PICTOOLS MEDICAL TOOL KIT MODEL 1.0, Substantially Equivalent on 1998-09-14. Applicant: Pegasus Imaging Corp..

Clearance details

Applicant: Pegasus Imaging Corp.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1998-06-17
Decision date: 1998-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

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.