CTXA HIP; CTXA; QCT PRO CTXA HIP— 510(k) K002113

Name: FDA 510(k) clearance K002113
Creator: U.S. Food and Drug Administration
Published: 2001-12-04

Substantially Equivalent

Mindways Software, Inc.

FDA 510(k) clearance K002113 for CTXA HIP; CTXA; QCT PRO CTXA HIP, Substantially Equivalent on 2001-12-04. Applicant: Mindways Software, Inc.. Device class: 2.

Clearance details

Applicant: Mindways Software, Inc.
Product code: Code KGI
Device class: Class 2
Regulation: 21 CFR 892.1170
Advisory panel: Radiology
Date received: 2000-06-07
Decision date: 2001-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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K140342 — QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT2014-08-29
K030330 — CTXA HIP EXTENDED REFERENCE DATA2003-06-20

Adverse events under product code KGI

product code KGI

Other: 1
Total: 1

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.