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)

EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3

K-Number: K010129 · 2001-04-05

ApplicantToshiba America Medical Systems, In.C
Decision Date2001-04-05
Product CodeLNI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba America Medical Systems, In.C. It received FDA 510(k) clearance on 2001-04-05 under 510(k) number K010129. The device is classified under product code LNI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3?

EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 is a medical device that received FDA 510(k) clearance on 2001-04-05. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K010129.

When did EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 receive FDA 510(k) clearance?

EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 received FDA 510(k) clearance on 2001-04-05, under 510(k) number K010129.

Who is the listed applicant for EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3?

The FDA 510(k) record lists Toshiba America Medical Systems, In.C as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3?

The FDA product code for EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 is LNI.

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 Toshiba America Medical Systems, In.C 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.

K132106INFINIX ANGIO WORKSTATION W/DTS SOFTWAREK131822ULTRAEXTEND USWS-900A V2.1 AND V3.1K123097DOSE TRACKING SYSTEM MODEL XIDF-DTS801K122613VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/USK121076ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGEK122842RADREX-I, SW V4.00 MODEL DRAD-3000E

View all 143 devices →

Related Devices (Code: LNI)

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.

K093044OASIS MRI SYSTEMHitachi Medical Systems America, Inc.K071506ECHELON SPECTROSCOPY PACKAGEHitachi Medical Systems America, Inc.K011604PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRIGe Medical Systems, Inc.K003575MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEMGE Medical SystemsK991568MR SPECTROSCOPY PACKAGEPhilips Medical Systems (Cleveland), Inc.K984167SAGE 7GE Medical Systems

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.

↑