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FDA 510(k)

VersaViewer

K-Number: K243651 · 2025-04-21

Decision Date2025-04-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VersaViewer is a medical device manufactured by GE Medical Systems SCS. It received FDA 510(k) clearance on 2025-04-21 under approval number K243651. 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 VersaViewer?

VersaViewer is a medical device that received FDA 510(k) clearance on 2025-04-21. It is manufactured by GE Medical Systems SCS. The 510(k) number is K243651.

When was VersaViewer approved by the FDA?

VersaViewer received FDA 510(k) clearance on 2025-04-21, under approval number K243651.

What company makes VersaViewer?

VersaViewer is manufactured by GE Medical Systems SCS.

What is the FDA product code for VersaViewer?

The FDA product code for VersaViewer is LLZ.

Other Devices by GE Medical Systems SCS

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Related Devices (Code: LLZ)

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.