PROWESS PRO-SIM— 510(k) K980379

Substantially Equivalent

Ssgi Prowess Systems

FDA 510(k) clearance K980379 for PROWESS PRO-SIM, Substantially Equivalent on 1998-05-18. Applicant: Ssgi Prowess Systems.

Clearance details

Applicant: Ssgi Prowess Systems
Product code: Code IYE
Advisory panel: Radiology
Date received: 1998-01-30
Decision date: 1998-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chico, CA, US

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.