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FDA 510(k)

WITT BIOMEDICAL IMAGE III

K-Number: K945582 · 1995-06-19

ApplicantWitt Biomedical Corporation
Decision Date1995-06-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

WITT BIOMEDICAL IMAGE III 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 1995-06-19 under 510(k) number K945582. 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 WITT BIOMEDICAL IMAGE III?

WITT BIOMEDICAL IMAGE III is a medical device that received FDA 510(k) clearance on 1995-06-19. The listed applicant is Witt Biomedical Corporation. The 510(k) number is K945582.

When did WITT BIOMEDICAL IMAGE III receive FDA 510(k) clearance?

WITT BIOMEDICAL IMAGE III received FDA 510(k) clearance on 1995-06-19, under 510(k) number K945582.

Who is the listed applicant for WITT BIOMEDICAL IMAGE III?

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 WITT BIOMEDICAL IMAGE III?

The FDA product code for WITT BIOMEDICAL IMAGE III 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.

K010058IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORKK973474WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITSK950436WITT BIOMEDICAL SERIES IVK923054WITT 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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