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FDA 510(k)

ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS

K-Number: K071972 · 2007-07-30

ApplicantAgfa Healthcare Corp.
Decision Date2007-07-30
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Healthcare Corp.. It received FDA 510(k) clearance on 2007-07-30 under 510(k) number K071972. 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 ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS?

ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS is a medical device that received FDA 510(k) clearance on 2007-07-30. The listed applicant is Agfa Healthcare Corp.. The 510(k) number is K071972.

When did ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS receive FDA 510(k) clearance?

ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS received FDA 510(k) clearance on 2007-07-30, under 510(k) number K071972.

Who is the listed applicant for ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS?

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

What is the FDA product code for ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS?

The FDA product code for ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS 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 Agfa Healthcare Corp. 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.

K071297IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)K071162AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS

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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