SONOS IMAGING SYSTEM (2000/2500 & 1000/1500)— 510(k) K952540

Substantially Equivalent

Hewlett-Packard Co.

FDA 510(k) clearance K952540 for SONOS IMAGING SYSTEM (2000/2500 & 1000/1500), Substantially Equivalent on 1996-03-11. Applicant: Hewlett-Packard Co..

Clearance details

Applicant: Hewlett-Packard Co.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1995-05-23
Decision date: 1996-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, 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.