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FDA 510(k)

CT COLONOGRAPHY II

K-Number: K041270 · 2004-05-27

ApplicantGeneral Electric Medical Systems
Decision Date2004-05-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT COLONOGRAPHY II is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Medical Systems. It received FDA 510(k) clearance on 2004-05-27 under 510(k) number K041270. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CT COLONOGRAPHY II?

CT COLONOGRAPHY II is a medical device that received FDA 510(k) clearance on 2004-05-27. The listed applicant is General Electric Medical Systems. The 510(k) number is K041270.

When did CT COLONOGRAPHY II receive FDA 510(k) clearance?

CT COLONOGRAPHY II received FDA 510(k) clearance on 2004-05-27, under 510(k) number K041270.

Who is the listed applicant for CT COLONOGRAPHY II?

The FDA 510(k) record lists General Electric Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT COLONOGRAPHY II?

The FDA product code for CT COLONOGRAPHY II is LLZ.

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Other records listing General Electric Medical Systems as applicant

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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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