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FDA 510(k)

EXCELART WITH PIANISSIMO

K-Number: K993803 · 2000-02-06

ApplicantToshiba America Mri, Inc.
Decision Date2000-02-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXCELART WITH PIANISSIMO is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba America Mri, Inc.. It received FDA 510(k) clearance on 2000-02-06 under 510(k) number K993803. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXCELART WITH PIANISSIMO?

EXCELART WITH PIANISSIMO is a medical device that received FDA 510(k) clearance on 2000-02-06. The listed applicant is Toshiba America Mri, Inc.. The 510(k) number is K993803.

When did EXCELART WITH PIANISSIMO receive FDA 510(k) clearance?

EXCELART WITH PIANISSIMO received FDA 510(k) clearance on 2000-02-06, under 510(k) number K993803.

Who is the listed applicant for EXCELART WITH PIANISSIMO?

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

What is the FDA product code for EXCELART WITH PIANISSIMO?

The FDA product code for EXCELART WITH PIANISSIMO is LNH.

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Other records listing Toshiba America Mri, 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.

K002531EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3K002522OPART, MODEL MRT-600K000549OPART, MODEL MRT-600K993574OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGONK991740OPART, MODEL MRT-600K991057EXTRA LARGE BODY COIL FOR OPART (MRT-600)

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Related Devices (Code: LNH)

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.

K261283APERTO Lucent MRI SystemFujifilm CorporationK261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd.K260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd.K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc.K254250MagicScan-1.5, GreenMR Serenity 1.5TXingaoyi Medical Equipment Co.,LtdK253808AIR Recon DLGE 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.

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