ORISON EMBRACE SYSTEM— 510(k) K070477

Substantially Equivalent

Orison Corporation

FDA 510(k) clearance K070477 for ORISON EMBRACE SYSTEM, Substantially Equivalent on 2007-03-09. Applicant: Orison Corporation.

Clearance details

Applicant: Orison Corporation
Product code: Code IYO
Advisory panel: Radiology
Date received: 2007-02-20
Decision date: 2007-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Johnson City, TN, US

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.