SIEMENS PHO/SONIC ALPHA 1000— 510(k) K802759

Substantially Equivalent

Siemens Gammasonics, Inc.

FDA 510(k) clearance K802759 for SIEMENS PHO/SONIC ALPHA 1000, Substantially Equivalent on 1981-01-07. Applicant: Siemens Gammasonics, Inc..

Clearance details

Applicant: Siemens Gammasonics, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1980-11-04
Decision date: 1981-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.