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FDA 510(k)

PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

K-Number: K112974 · 2011-10-20

ApplicantCurve Dental, Inc.
Decision Date2011-10-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Curve Dental, Inc.. It received FDA 510(k) clearance on 2011-10-20 under 510(k) number K112974. 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 PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM?

PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM is a medical device that received FDA 510(k) clearance on 2011-10-20. The listed applicant is Curve Dental, Inc.. The 510(k) number is K112974.

When did PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM receive FDA 510(k) clearance?

PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM received FDA 510(k) clearance on 2011-10-20, under 510(k) number K112974.

Who is the listed applicant for PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM?

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

What is the FDA product code for PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM?

The FDA product code for PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM is LLZ.

Related Clinical Trials

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Other records listing Curve Dental, 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.

K110139CURVE IMAGE

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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