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FDA 510(k)

MEDI-6000 MEDICAL IMAGE DIGITIZER

K-Number: K091288 · 2009-08-14

ApplicantMicrotek International, Inc.
Decision Date2009-08-14
Product CodeLMA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDI-6000 MEDICAL IMAGE DIGITIZER is the device name listed in this FDA 510(k) record. The listed applicant is Microtek International, Inc.. It received FDA 510(k) clearance on 2009-08-14 under 510(k) number K091288. The device is classified under product code LMA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDI-6000 MEDICAL IMAGE DIGITIZER?

MEDI-6000 MEDICAL IMAGE DIGITIZER is a medical device that received FDA 510(k) clearance on 2009-08-14. The listed applicant is Microtek International, Inc.. The 510(k) number is K091288.

When did MEDI-6000 MEDICAL IMAGE DIGITIZER receive FDA 510(k) clearance?

MEDI-6000 MEDICAL IMAGE DIGITIZER received FDA 510(k) clearance on 2009-08-14, under 510(k) number K091288.

Who is the listed applicant for MEDI-6000 MEDICAL IMAGE DIGITIZER?

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

What is the FDA product code for MEDI-6000 MEDICAL IMAGE DIGITIZER?

The FDA product code for MEDI-6000 MEDICAL IMAGE DIGITIZER is LMA.

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Related Devices (Code: LMA)

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.

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