FDA 510(k)

Xeleris 4.0 Processing and Review Workstation

K-Number: K153355 · 2016-03-16

Decision Date2016-03-16

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Xeleris 4.0 Processing and Review Workstation is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2016-03-16 under 510(k) number K153355. 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 Xeleris 4.0 Processing and Review Workstation?

Xeleris 4.0 Processing and Review Workstation is a medical device that received FDA 510(k) clearance on 2016-03-16. The listed applicant is GE Healthcare. The 510(k) number is K153355.

When did Xeleris 4.0 Processing and Review Workstation receive FDA 510(k) clearance?

Xeleris 4.0 Processing and Review Workstation received FDA 510(k) clearance on 2016-03-16, under 510(k) number K153355.

Who is the listed applicant for Xeleris 4.0 Processing and Review Workstation?

The FDA 510(k) record lists GE Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xeleris 4.0 Processing and Review Workstation?

The FDA product code for Xeleris 4.0 Processing and Review Workstation is LLZ.

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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.