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)

ARTIS ZEE / ZEEGOS WITH SW VC14

K-Number: K090745 · 2009-06-18

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2009-06-18
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ARTIS ZEE / ZEEGOS WITH SW VC14 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2009-06-18 under 510(k) number K090745. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTIS ZEE / ZEEGOS WITH SW VC14?

ARTIS ZEE / ZEEGOS WITH SW VC14 is a medical device that received FDA 510(k) clearance on 2009-06-18. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K090745.

When did ARTIS ZEE / ZEEGOS WITH SW VC14 receive FDA 510(k) clearance?

ARTIS ZEE / ZEEGOS WITH SW VC14 received FDA 510(k) clearance on 2009-06-18, under 510(k) number K090745.

Who is the listed applicant for ARTIS ZEE / ZEEGOS WITH SW VC14?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTIS ZEE / ZEEGOS WITH SW VC14?

The FDA product code for ARTIS ZEE / ZEEGOS WITH SW VC14 is IZI.

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 Siemens Medical Solutions USA, 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.

K260055syngo.CT Brain QuantificationK261696ACUNAV Luxera 4D ICE CatheterK260488MULTIX Impact; MULTIX Impact CK253786syngo.CT Coronary CockpitK253678MAMMOMAT B.brilliant (11372950)K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System

View all 732 devices →

Related Devices (Code: IZI)

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.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

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.

↑