FDA 510(k)

Medisystem Pacs

K-Number: K223048 · 2023-06-23

ApplicantMedilab Manutencao E Sitemas Ltda

Decision Date2023-06-23

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Medisystem Pacs is the device name listed in this FDA 510(k) record. The listed applicant is Medilab Manutencao E Sitemas Ltda. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K223048. 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 Medisystem Pacs?

Medisystem Pacs is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is Medilab Manutencao E Sitemas Ltda. The 510(k) number is K223048.

When did Medisystem Pacs receive FDA 510(k) clearance?

Medisystem Pacs received FDA 510(k) clearance on 2023-06-23, under 510(k) number K223048.

Who is the listed applicant for Medisystem Pacs?

The FDA 510(k) record lists Medilab Manutencao E Sitemas Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medisystem Pacs?

The FDA product code for Medisystem Pacs is LLZ.

Related Devices (Code: LLZ)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.