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FDA 510(k)

MAROSIS PACS

K-Number: K012844 · 2001-11-08

ApplicantMarotech, Inc.
Decision Date2001-11-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAROSIS PACS is the device name listed in this FDA 510(k) record. The listed applicant is Marotech, Inc.. It received FDA 510(k) clearance on 2001-11-08 under 510(k) number K012844. 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 MAROSIS PACS?

MAROSIS PACS is a medical device that received FDA 510(k) clearance on 2001-11-08. The listed applicant is Marotech, Inc.. The 510(k) number is K012844.

When did MAROSIS PACS receive FDA 510(k) clearance?

MAROSIS PACS received FDA 510(k) clearance on 2001-11-08, under 510(k) number K012844.

Who is the listed applicant for MAROSIS PACS?

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

What is the FDA product code for MAROSIS PACS?

The FDA product code for MAROSIS PACS is LLZ.

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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

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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