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FDA 510(k)

CTXA HIP; CTXA; QCT PRO CTXA HIP

K-Number: K002113 · 2001-12-04

ApplicantMindways Software, Inc.
Decision Date2001-12-04
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CTXA HIP; CTXA; QCT PRO CTXA HIP is the device name listed in this FDA 510(k) record. The listed applicant is Mindways Software, Inc.. It received FDA 510(k) clearance on 2001-12-04 under 510(k) number K002113. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CTXA HIP; CTXA; QCT PRO CTXA HIP?

CTXA HIP; CTXA; QCT PRO CTXA HIP is a medical device that received FDA 510(k) clearance on 2001-12-04. The listed applicant is Mindways Software, Inc.. The 510(k) number is K002113.

When did CTXA HIP; CTXA; QCT PRO CTXA HIP receive FDA 510(k) clearance?

CTXA HIP; CTXA; QCT PRO CTXA HIP received FDA 510(k) clearance on 2001-12-04, under 510(k) number K002113.

Who is the listed applicant for CTXA HIP; CTXA; QCT PRO CTXA HIP?

The FDA 510(k) record lists Mindways Software, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CTXA HIP; CTXA; QCT PRO CTXA HIP?

The FDA product code for CTXA HIP; CTXA; QCT PRO CTXA HIP is KGI.

Other records listing Mindways Software, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K030330CTXA HIP EXTENDED REFERENCE DATA

Related Devices (Code: KGI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254072BoneVueCurvebeam AI / Curvebeam, LLCK252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLCK2510223D-SHAPER3D-Shaper Medical S.LK242295BunkerHill BMDBunkerHill HealthK243218TBS iNsight (V4)Medimaps Group SAK220402VirtuOstO.N. Diagnostics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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