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)

MRT-35A V9.0

K-Number: K964608 · 1997-02-04

ApplicantToshiba America Mri, Inc.
Decision Date1997-02-04
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRT-35A V9.0 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 1997-02-04 under 510(k) number K964608. 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 MRT-35A V9.0?

MRT-35A V9.0 is a medical device that received FDA 510(k) clearance on 1997-02-04. The listed applicant is Toshiba America Mri, Inc.. The 510(k) number is K964608.

When did MRT-35A V9.0 receive FDA 510(k) clearance?

MRT-35A V9.0 received FDA 510(k) clearance on 1997-02-04, under 510(k) number K964608.

Who is the listed applicant for MRT-35A V9.0?

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 MRT-35A V9.0?

The FDA product code for MRT-35A V9.0 is LNH.

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.

↑