RCHIVE PACS— 510(k) K063253

Substantially Equivalent

Sobha Renaissance Information Technology Pvt, Ltd.

FDA 510(k) clearance K063253 for RCHIVE PACS, Substantially Equivalent on 2006-12-12. Applicant: Sobha Renaissance Information Technology Pvt, Ltd..

Clearance details

Applicant: Sobha Renaissance Information Technology Pvt, Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2006-10-27
Decision date: 2006-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denton, TX, 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.