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FDA 510(k)

Xeleris 4.0 Processing and Review Workstation

K-Number: K153355 · 2016-03-16

ApplicantGE Healthcare
Decision Date2016-03-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Xeleris 4.0 Processing and Review Workstation is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2016-03-16 under approval 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. It is manufactured by GE Healthcare. The 510(k) number is K153355.

When was Xeleris 4.0 Processing and Review Workstation approved by the FDA?

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

What company makes Xeleris 4.0 Processing and Review Workstation?

Xeleris 4.0 Processing and Review Workstation is manufactured by GE Healthcare.

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.

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