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FDA 510(k)

CSI/QCT

K-Number: K880404 · 1988-11-17

ApplicantColumbia Scientific, Inc.
Decision Date1988-11-17
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CSI/QCT is the device name listed in this FDA 510(k) record. The listed applicant is Columbia Scientific, Inc.. It received FDA 510(k) clearance on 1988-11-17 under 510(k) number K880404. 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 CSI/QCT?

CSI/QCT is a medical device that received FDA 510(k) clearance on 1988-11-17. The listed applicant is Columbia Scientific, Inc.. The 510(k) number is K880404.

When did CSI/QCT receive FDA 510(k) clearance?

CSI/QCT received FDA 510(k) clearance on 1988-11-17, under 510(k) number K880404.

Who is the listed applicant for CSI/QCT?

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

What is the FDA product code for CSI/QCT?

The FDA product code for CSI/QCT is KGI.

Other records listing Columbia Scientific, 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.

K011180CT/MASTER, VERSION 1.0K924810SIM/PLANTK897000IMAGEMASTER-101(TM)K8853223D/DENTALK870513CSI/3DK861852CSI/MPR OR CSI/MPR PLUS

View all 7 devices →

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

View on FDA Database →

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

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