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FDA 510(k)

ORACLE MRI WHOLE BODY MR IMAGING SYSTEM

K-Number: K942953 · 1994-09-30

ApplicantOtsuka Electronics USA, Inc.
Decision Date1994-09-30
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORACLE MRI WHOLE BODY MR IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Otsuka Electronics USA, Inc.. It received FDA 510(k) clearance on 1994-09-30 under 510(k) number K942953. 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 ORACLE MRI WHOLE BODY MR IMAGING SYSTEM?

ORACLE MRI WHOLE BODY MR IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1994-09-30. The listed applicant is Otsuka Electronics USA, Inc.. The 510(k) number is K942953.

When did ORACLE MRI WHOLE BODY MR IMAGING SYSTEM receive FDA 510(k) clearance?

ORACLE MRI WHOLE BODY MR IMAGING SYSTEM received FDA 510(k) clearance on 1994-09-30, under 510(k) number K942953.

Who is the listed applicant for ORACLE MRI WHOLE BODY MR IMAGING SYSTEM?

The FDA 510(k) record lists Otsuka Electronics USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORACLE MRI WHOLE BODY MR IMAGING SYSTEM?

The FDA product code for ORACLE MRI WHOLE BODY MR IMAGING SYSTEM is LNH.

Related Clinical Trials

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Other records listing Otsuka Electronics USA, 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.

K942776MAGNETIC RESONANCE ANGIOGRAPHY CAPABILITY/OE 1.5 S1

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

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