BREAST SIMULATION SYSTEM— 510(k) K925714

Substantially Equivalent

Severn Research, Inc.

FDA 510(k) clearance K925714 for BREAST SIMULATION SYSTEM, Substantially Equivalent on 1993-06-08. Applicant: Severn Research, Inc..

Clearance details

Applicant: Severn Research, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 1992-11-12
Decision date: 1993-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Annapolis, MD, 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.