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FDA 510(k)

CSIST DICOM GATEWAY/IMAGE MANAGER

K-Number: K012327 · 2001-12-20

ApplicantCsist
Decision Date2001-12-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CSIST DICOM GATEWAY/IMAGE MANAGER is the device name listed in this FDA 510(k) record. The listed applicant is Csist. It received FDA 510(k) clearance on 2001-12-20 under 510(k) number K012327. 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 CSIST DICOM GATEWAY/IMAGE MANAGER?

CSIST DICOM GATEWAY/IMAGE MANAGER is a medical device that received FDA 510(k) clearance on 2001-12-20. The listed applicant is Csist. The 510(k) number is K012327.

When did CSIST DICOM GATEWAY/IMAGE MANAGER receive FDA 510(k) clearance?

CSIST DICOM GATEWAY/IMAGE MANAGER received FDA 510(k) clearance on 2001-12-20, under 510(k) number K012327.

Who is the listed applicant for CSIST DICOM GATEWAY/IMAGE MANAGER?

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

What is the FDA product code for CSIST DICOM GATEWAY/IMAGE MANAGER?

The FDA product code for CSIST DICOM GATEWAY/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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