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FDA 510(k)

Legend X Desktop System

K-Number: K243217 · 2024-11-01

ApplicantPollogen, Ltd.
Decision Date2024-11-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Legend X Desktop System is the device name listed in this FDA 510(k) record. The listed applicant is Pollogen, Ltd.. It received FDA 510(k) clearance on 2024-11-01 under 510(k) number K243217. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Legend X Desktop System?

Legend X Desktop System is a medical device that received FDA 510(k) clearance on 2024-11-01. The listed applicant is Pollogen, Ltd.. The 510(k) number is K243217.

When did Legend X Desktop System receive FDA 510(k) clearance?

Legend X Desktop System received FDA 510(k) clearance on 2024-11-01, under 510(k) number K243217.

Who is the listed applicant for Legend X Desktop System?

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

What is the FDA product code for Legend X Desktop System?

The FDA product code for Legend X Desktop System is GEI.

Other records listing Pollogen, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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