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FDA 510(k)

CT/MASTER, VERSION 1.0

K-Number: K011180 · 2001-06-27

ApplicantColumbia Scientific, Inc.
Decision Date2001-06-27
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT/MASTER, VERSION 1.0 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 2001-06-27 under 510(k) number K011180. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CT/MASTER, VERSION 1.0?

CT/MASTER, VERSION 1.0 is a medical device that received FDA 510(k) clearance on 2001-06-27. The listed applicant is Columbia Scientific, Inc.. The 510(k) number is K011180.

When did CT/MASTER, VERSION 1.0 receive FDA 510(k) clearance?

CT/MASTER, VERSION 1.0 received FDA 510(k) clearance on 2001-06-27, under 510(k) number K011180.

Who is the listed applicant for CT/MASTER, VERSION 1.0?

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 CT/MASTER, VERSION 1.0?

The FDA product code for CT/MASTER, VERSION 1.0 is JAK.

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Other records listing Columbia Scientific, Inc. as applicant

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Related Devices (Code: JAK)

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.

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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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