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

Name: FDA 510(k) clearance K984406
Creator: U.S. Food and Drug Administration
Published: 1999-02-02

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.. Device class: 2.

Clearance details

Applicant: Xitec, Inc.
Product code: Code OXO
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 1998-12-09
Decision date: 1999-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OXO

view all

K253296 — Digital C-ARM with 3D2026-06-05
K252579 — Orthoscan TAU MVP Mini C-Arm System2026-01-14
K253269 — OEC One CFD2025-11-26
K251004 — Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)2025-11-06
K250587 — Orthoscan TAU Mini C-Arm2025-07-02

More clearances from Xitec, Inc.

view all

K003568 — XISCAN 6000 IMAGING SYSTEM2000-12-27

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.