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FDA 510(k)

CA-1500

K-Number: K040028 · 2004-01-22

ApplicantR2 Technology, Inc.
Decision Date2004-01-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CA-1500 is the device name listed in this FDA 510(k) record. The listed applicant is R2 Technology, Inc.. It received FDA 510(k) clearance on 2004-01-22 under 510(k) number K040028. 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 CA-1500?

CA-1500 is a medical device that received FDA 510(k) clearance on 2004-01-22. The listed applicant is R2 Technology, Inc.. The 510(k) number is K040028.

When did CA-1500 receive FDA 510(k) clearance?

CA-1500 received FDA 510(k) clearance on 2004-01-22, under 510(k) number K040028.

Who is the listed applicant for CA-1500?

The FDA 510(k) record lists R2 Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CA-1500?

The FDA product code for CA-1500 is LLZ.

Other records listing R2 Technology, 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.

K051743R2 BREAST IMAGING WORKSTATIONK050667R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWAREK041380IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATORK023003IMAGECHECKER-CT WORKSTATION

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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