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FDA 510(k)

MDIFICATION TO MEDIPRIME

K-Number: K033013 · 2003-11-25

ApplicantAlgotec Systems, Ltd.
Decision Date2003-11-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MDIFICATION TO MEDIPRIME is the device name listed in this FDA 510(k) record. The listed applicant is Algotec Systems, Ltd.. It received FDA 510(k) clearance on 2003-11-25 under 510(k) number K033013. 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 MDIFICATION TO MEDIPRIME?

MDIFICATION TO MEDIPRIME is a medical device that received FDA 510(k) clearance on 2003-11-25. The listed applicant is Algotec Systems, Ltd.. The 510(k) number is K033013.

When did MDIFICATION TO MEDIPRIME receive FDA 510(k) clearance?

MDIFICATION TO MEDIPRIME received FDA 510(k) clearance on 2003-11-25, under 510(k) number K033013.

Who is the listed applicant for MDIFICATION TO MEDIPRIME?

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

What is the FDA product code for MDIFICATION TO MEDIPRIME?

The FDA product code for MDIFICATION TO MEDIPRIME 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 Algotec Systems, Ltd. 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.

K023936MODIFICATION TO MEDIPRIMEK002894MEDIPRIMEK980648PRO VISIONK954678PRO VISION

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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