FDA 510(k)

IMAC2000

K-Number: K911764 · 1991-09-23

ApplicantMedical Imaging Technologies, Inc.

Decision Date1991-09-23

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

IMAC2000 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Imaging Technologies, Inc.. It received FDA 510(k) clearance on 1991-09-23 under 510(k) number K911764. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAC2000?

IMAC2000 is a medical device that received FDA 510(k) clearance on 1991-09-23. The listed applicant is Medical Imaging Technologies, Inc.. The 510(k) number is K911764.

When did IMAC2000 receive FDA 510(k) clearance?

IMAC2000 received FDA 510(k) clearance on 1991-09-23, under 510(k) number K911764.

Who is the listed applicant for IMAC2000?

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

What is the FDA product code for IMAC2000?

The FDA product code for IMAC2000 is JAK.

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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.