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FDA 510(k)

Xeleris V Processing and Review System

K-Number: K221680 · 2023-03-01

ApplicantGE Healthcare
Decision Date2023-03-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Xeleris V Processing and Review System is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2023-03-01 under approval number K221680. 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 V Processing and Review System?

Xeleris V Processing and Review System is a medical device that received FDA 510(k) clearance on 2023-03-01. It is manufactured by GE Healthcare. The 510(k) number is K221680.

When was Xeleris V Processing and Review System approved by the FDA?

Xeleris V Processing and Review System received FDA 510(k) clearance on 2023-03-01, under approval number K221680.

What company makes Xeleris V Processing and Review System?

Xeleris V Processing and Review System is manufactured by GE Healthcare.

What is the FDA product code for Xeleris V Processing and Review System?

The FDA product code for Xeleris V Processing and Review System is LLZ.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026)

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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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