IPACS PRISM-5.0— 510(k) K050298

Substantially Equivalent

Realtimeimage, Inc.

FDA 510(k) clearance K050298 for IPACS PRISM-5.0, Substantially Equivalent on 2005-02-28. Applicant: Realtimeimage, Inc..

Clearance details

Applicant: Realtimeimage, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2005-02-07
Decision date: 2005-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denton, TX, US

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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.