XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM— 510(k) K984406

Substantially Equivalent

Xitec, Inc.

FDA 510(k) clearance K984406 for XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM, Substantially Equivalent on 1999-02-02. Applicant: Xitec, Inc..

Clearance details

Applicant: Xitec, Inc.
Product code: Code OXO
Advisory panel: Radiology
Date received: 1998-12-09
Decision date: 1999-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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Adverse events under product code OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

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.