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FDA 510(k)

MITS DICOM GATEWAY AND IMAGE MANAGER

K-Number: K092581 · 2009-10-30

ApplicantMitsmed Medical Instrument Technology Co., Ltd.
Decision Date2009-10-30
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MITS DICOM GATEWAY AND IMAGE MANAGER is the device name listed in this FDA 510(k) record. The listed applicant is Mitsmed Medical Instrument Technology Co., Ltd.. It received FDA 510(k) clearance on 2009-10-30 under 510(k) number K092581. 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 MITS DICOM GATEWAY AND IMAGE MANAGER?

MITS DICOM GATEWAY AND IMAGE MANAGER is a medical device that received FDA 510(k) clearance on 2009-10-30. The listed applicant is Mitsmed Medical Instrument Technology Co., Ltd.. The 510(k) number is K092581.

When did MITS DICOM GATEWAY AND IMAGE MANAGER receive FDA 510(k) clearance?

MITS DICOM GATEWAY AND IMAGE MANAGER received FDA 510(k) clearance on 2009-10-30, under 510(k) number K092581.

Who is the listed applicant for MITS DICOM GATEWAY AND IMAGE MANAGER?

The FDA 510(k) record lists Mitsmed Medical Instrument Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MITS DICOM GATEWAY AND IMAGE MANAGER?

The FDA product code for MITS DICOM GATEWAY AND IMAGE MANAGER is LLZ.

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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.

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