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)

VERTIX 3D-U

K-Number: K802200 · 1980-10-23

ApplicantSiemens Corp.
Decision Date1980-10-23
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VERTIX 3D-U is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Corp.. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K802200. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERTIX 3D-U?

VERTIX 3D-U is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Siemens Corp.. The 510(k) number is K802200.

When did VERTIX 3D-U receive FDA 510(k) clearance?

VERTIX 3D-U received FDA 510(k) clearance on 1980-10-23, under 510(k) number K802200.

Who is the listed applicant for VERTIX 3D-U?

The FDA 510(k) record lists Siemens Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERTIX 3D-U?

The FDA product code for VERTIX 3D-U is KPR.

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 Corp. 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.

K103360DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CALK993947KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILYK992925AX WORKSTATION DR-VIEWER SOFTWARE OPTIONK991652HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEMK991600SOMATOM PLUS 4 WITH SLIDING GANTRY OPTIONK984221FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR

View all 66 devices →

Related Devices (Code: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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.

↑