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FDA 510(k)

IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK

K-Number: K010058 · 2001-03-21

ApplicantWitt Biomedical Corporation
Decision Date2001-03-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK is the device name listed in this FDA 510(k) record. The listed applicant is Witt Biomedical Corporation. It received FDA 510(k) clearance on 2001-03-21 under 510(k) number K010058. 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 IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK?

IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK is a medical device that received FDA 510(k) clearance on 2001-03-21. The listed applicant is Witt Biomedical Corporation. The 510(k) number is K010058.

When did IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK receive FDA 510(k) clearance?

IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK received FDA 510(k) clearance on 2001-03-21, under 510(k) number K010058.

Who is the listed applicant for IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK?

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

What is the FDA product code for IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK?

The FDA product code for IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK is LLZ.

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Other records listing Witt Biomedical Corporation as applicant

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.

K973474WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITSK950436WITT BIOMEDICAL SERIES IVK945582WITT BIOMEDICAL IMAGE IIIK923054WITT BIOMEDICAL SERIES II-EPK880258WITT BIOMEDICAL VX-80

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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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