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FDA 510(k)

NETRA WORKSTATION AND NETRAMD SOFTWARE

K-Number: K003484 · 2001-01-19

ApplicantScimage, Inc.
Decision Date2001-01-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NETRA WORKSTATION AND NETRAMD SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Scimage, Inc.. It received FDA 510(k) clearance on 2001-01-19 under 510(k) number K003484. 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 NETRA WORKSTATION AND NETRAMD SOFTWARE?

NETRA WORKSTATION AND NETRAMD SOFTWARE is a medical device that received FDA 510(k) clearance on 2001-01-19. The listed applicant is Scimage, Inc.. The 510(k) number is K003484.

When did NETRA WORKSTATION AND NETRAMD SOFTWARE receive FDA 510(k) clearance?

NETRA WORKSTATION AND NETRAMD SOFTWARE received FDA 510(k) clearance on 2001-01-19, under 510(k) number K003484.

Who is the listed applicant for NETRA WORKSTATION AND NETRAMD SOFTWARE?

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

What is the FDA product code for NETRA WORKSTATION AND NETRAMD SOFTWARE?

The FDA product code for NETRA WORKSTATION AND NETRAMD SOFTWARE is LLZ.

Related Clinical Trials

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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Other records listing Scimage, Inc. 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.

K073169SCIMAGE PICOMENTERPRISEK960911NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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