Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KMC-950 C-ARM MOBILE SYSTEM

K-Number: K032761 · 2004-05-14

ApplicantUnited Radiology Systems, Inc.
Decision Date2004-05-14
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KMC-950 C-ARM MOBILE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is United Radiology Systems, Inc.. It received FDA 510(k) clearance on 2004-05-14 under 510(k) number K032761. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KMC-950 C-ARM MOBILE SYSTEM?

KMC-950 C-ARM MOBILE SYSTEM is a medical device that received FDA 510(k) clearance on 2004-05-14. The listed applicant is United Radiology Systems, Inc.. The 510(k) number is K032761.

When did KMC-950 C-ARM MOBILE SYSTEM receive FDA 510(k) clearance?

KMC-950 C-ARM MOBILE SYSTEM received FDA 510(k) clearance on 2004-05-14, under 510(k) number K032761.

Who is the listed applicant for KMC-950 C-ARM MOBILE SYSTEM?

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

What is the FDA product code for KMC-950 C-ARM MOBILE SYSTEM?

The FDA product code for KMC-950 C-ARM MOBILE SYSTEM is OWB.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing United Radiology Systems, 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.

K032628PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF

Related Devices (Code: OWB)

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.

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH CorporationK254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.

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.

↑