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FDA 510(k)

ORTHO-CMS

K-Number: K041162 · 2004-07-27

ApplicantMedis Medical Imaging Systems BV
Decision Date2004-07-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORTHO-CMS is the device name listed in this FDA 510(k) record. The listed applicant is Medis Medical Imaging Systems BV. It received FDA 510(k) clearance on 2004-07-27 under 510(k) number K041162. 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 ORTHO-CMS?

ORTHO-CMS is a medical device that received FDA 510(k) clearance on 2004-07-27. The listed applicant is Medis Medical Imaging Systems BV. The 510(k) number is K041162.

When did ORTHO-CMS receive FDA 510(k) clearance?

ORTHO-CMS received FDA 510(k) clearance on 2004-07-27, under 510(k) number K041162.

Who is the listed applicant for ORTHO-CMS?

The FDA 510(k) record lists Medis Medical Imaging Systems BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHO-CMS?

The FDA product code for ORTHO-CMS is LLZ.

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Other records listing Medis Medical Imaging Systems BV 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.

K182611Qangio XA 3DK112807X-RAY VVAK073156QPLAQUE MRK062386QANGIO CTK050703QBRAINK042383RSA-CMS

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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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