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FDA 510(k)

OPART

K-Number: K990260 · 1999-04-15

ApplicantToshiba America Mri, Inc.
Decision Date1999-04-15
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPART 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 1999-04-15 under 510(k) number K990260. 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 OPART?

OPART is a medical device that received FDA 510(k) clearance on 1999-04-15. The listed applicant is Toshiba America Mri, Inc.. The 510(k) number is K990260.

When did OPART receive FDA 510(k) clearance?

OPART received FDA 510(k) clearance on 1999-04-15, under 510(k) number K990260.

Who is the listed applicant for OPART?

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 OPART?

The FDA product code for OPART is LNH.

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Related PubMed Literature

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.

PMID: 33050694Unravelling the Immunotoxicity of Polycaprolactone Nanoparticles-Effects of Polymer Molecular Weight, Hydrolysis, and Blends.Chemical research in toxicology ()

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-600K993803EXCELART WITH PIANISSIMOK993574OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGONK991740OPART, MODEL MRT-600

View all 68 devices →

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.

K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd.K261283APERTO Lucent MRI SystemFujifilm CorporationK260758MAGNETOM 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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