SONOS 5500 IMAGING SYSTEM— 510(k) K971116

Substantially Equivalent

Hewlett-Packard Co.

FDA 510(k) clearance K971116 for SONOS 5500 IMAGING SYSTEM, Substantially Equivalent on 1998-01-12. Applicant: Hewlett-Packard Co..

Clearance details

Applicant: Hewlett-Packard Co.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1997-03-26
Decision date: 1998-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

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Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.